The following data is part of a premarket notification filed by Isomedix Operations Inc. with the FDA for Schneider Gex(tm) .014/.018 Guidewire Exchange Catheter.
| Device ID | K950047 |
| 510k Number | K950047 |
| Device Name: | SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | ISOMEDIX OPERATIONS INC. 1880 INDUSTRIAL DR. Libertyville, IL 60048 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-05 |
| Decision Date | 1995-04-05 |