teleflex.comPHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
BIOTRONIK AG
BIOTRONIK AG
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 8043892 | 3002808050 | BIOTRONIK AG | 1 | N | 2026-01-01 | ACKERSTRASSE 6 BULACH Zurich CH CH-8180 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07640130451490 | Passeo-35 Xeo - 4/20/90 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130451506 | Passeo-35 Xeo - 5/20/90 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130451513 | Passeo-35 Xeo - 6/20/90 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130451520 | Passeo-35 Xeo - 7/20/90 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130451537 | Passeo-35 Xeo - 8/20/90 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130451544 | Passeo-35 Xeo - 9/20/90 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130451551 | Passeo-35 Xeo - 10/20/90 | 612-423-1738 | FDA.US.Agent@teleflex.com |
| 07640130451575 | Passeo-35 Xeo - 3/40/90 | 612-423-1738 | FDA.US.Agent@teleflex.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 83935 | 1263247262 | P170030 | ORSIRO Sirolimus Eluting Coronary Stent System | NIQ | 2019-02-22 |
| 83935 | 1895965527 | P160025 | ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM | NIP | 2017-03-23 |
| 83935 | 1632727540 | P160003 | PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM | MAF | 2017-02-14 |
| 83935 | 1793172198 | P140030 | ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM | NIO | 2015-12-17 |
| 83935 | 1284326705 | K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | LIT | 2025-04-04 |
| 83935 | 1657566336 | K163660 | Pantera LEO | LOX | 2017-01-26 |
| 83935 | 1056585236 | K160985 | Pantera Pro | LOX | 2016-10-07 |
| 83935 | 1855338479 | K153197 | Fortress Introducer Sheath SYstem | DYB | 2016-01-11 |
| 83935 | 1927430492 | K152240 | Passeo-14 Peripheral Dilatation Catheter | LIT | 2015-10-08 |
| 83935 | 1236732730 | K142379 | Passeo-35 PTA Catheter | LIT | 2014-12-05 |
| 83935 | 1856160047 | K130146 | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM | NDN | 2013-05-20 |
| 83935 | 2044718311 | K113468 | ELM PTA BALLON DILATATION CATHETER | LIT | 2011-12-20 |
| 83935 | 1802528173 | K102211 | CRUISER 18 GUIDEWIRE | DQX | 2010-09-03 |
| 83935 | 1828161358 | K100799 | FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815 | DYB | 2011-02-25 |
| 83935 | 1961452980 | K090193 | CONDUCTOR CORONARY GUIDEWIRE | DQX | 2009-09-25 |
| 83935 | 2072213833 | K082933 | PASSEO-35 PTA CATHETER | DQY | 2008-11-03 |
| 83935 | 1317498973 | K072765 | PASSEO 18 | LIT | 2007-12-12 |
| 83935 | 1038367706 | H170004 |
Product Codes Associated With Registrations
PMN
GUDID
Passeo-35 Xeo - 4/20/90
2023-02-28
Passeo-35 Xeo - 5/20/90
2023-02-28
Passeo-35 Xeo - 6/20/90
2023-02-28
Passeo-35 Xeo - 7/20/90
2023-02-28
Passeo-35 Xeo - 8/20/90
2023-02-28
Passeo-35 Xeo - 9/20/90
2023-02-28
Passeo-35 Xeo - 10/20/90
2023-02-28
Passeo-35 Xeo - 3/40/90
2023-02-28
Passeo-35 Xeo - 4/40/90
2023-02-28
Passeo-35 Xeo - 5/40/90
2023-02-28
Passeo-35 Xeo - 6/40/90
2023-02-28
Passeo-35 Xeo - 7/40/90
2023-02-28
Passeo-35 Xeo - 8/40/90
2023-02-28
Passeo-35 Xeo - 9/40/90
2023-02-28
Passeo-35 Xeo - 10/40/90
2023-02-28
Passeo-35 Xeo - 12/40/90
2023-02-28
Passeo-35 Xeo - 3/60/90
2023-02-28
Passeo-35 Xeo - 4/60/90
2023-02-28
Passeo-35 Xeo - 5/60/90
2023-02-28
Passeo-35 Xeo - 6/60/90
2023-02-28
Passeo-35 Xeo - 7/60/90
2023-02-28
Passeo-35 Xeo - 8/60/90
2023-02-28
Passeo-35 Xeo - 9/60/90
2023-02-28
Passeo-35 Xeo - 10/60/90
2023-02-28
Passeo-35 Xeo - 12/60/90
2023-02-28
Passeo-35 Xeo - 3/80/90
2023-02-28
Passeo-35 Xeo - 4/80/90
2023-02-28
Passeo-35 Xeo - 5/80/90
2023-02-28
Passeo-35 Xeo - 6/80/90
2023-02-28
Passeo-35 Xeo - 7/80/90
2023-02-28
Passeo-35 Xeo - 8/80/90
2023-02-28
Passeo-35 Xeo - 9/80/90
2023-02-28
Passeo-35 Xeo - 10/80/90
2023-02-28
Passeo-35 Xeo - 12/80/90
2023-02-28
Passeo-35 Xeo - 3/100/90
2023-02-28
Passeo-35 Xeo - 4/100/90
2023-02-28
Passeo-35 Xeo - 5/100/90
2023-02-28
Passeo-35 Xeo - 6/100/90
2023-02-28
Passeo-35 Xeo - 7/100/90
2023-02-28
Passeo-35 Xeo - 8/100/90
2023-02-28