BIOSENSE WEBSTER, INC.
Registration 3013300026FEI 3013300026Irvine, CA
Owner/operator: BIOSENSE WEBSTER, INC.
- Complaint File Establishment per 21 CFR 820.198
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 88
- Added, last 12 months
- 2
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 88
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| LPB | CELSIUS® RMT THERMOCOOL® Diagnostic/Ablation CathetersCardiac Ablation Percutaneous Catheter | Class 3 | — | P030031 |
| LPB | TRUEPULSE GeneratorCardiac Ablation Percutaneous Catheter | Class 3 | — | — |
| LPB | CELSIUS® FLTR Diagnostic/Ablation Steerable Tip CathetersCardiac Ablation Percutaneous Catheter | Class 3 | — | P950005 |
| LPB | EZ Steer Nav Bi-Directional Electrophysiology CatheterCardiac Ablation Percutaneous Catheter | Class 3 | — | P990025 |
| LPB | EZ Steer ThermoCool Nav Bi-Directional Electrophysiology CatheterCardiac Ablation Percutaneous Catheter | Class 3 | — | P040036 |
| LPB | CARTO System Interface CableCardiac Ablation Percutaneous Catheter | Class 3 | — | P990071 |
| OAE | CELSIUS® RMT THERMOCOOL® Diagnostic/Ablation CathetersCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class 3 | — | P030031 |
| OAE | Dual Energy THERMOCOOL SMARTTOUCH SF CatheterCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class 3 | — | — |
| OAE | QDOT MICRO CatheterCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class 3 | — | P210027 |
| OAE | CARTO System Interface CableCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Class 3 | — | P990071 |
| OAD | CARTO System Interface CableCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | Class 3 | — | P990071 |
| OAD | CELSIUS FLTR CatheterCatheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | Class 3 | — | P010068 |
and 76 more on your full dossier
What changed
- Jan 28, 2026Listing added: DQK — CARTO 3 EP Navigation System V9 with PIU Plus (K254085)
- Mar 2, 2026Listing added: DQK — CARTO 3 EP Navigation System V8.4 (K252972)