The following data is part of a premarket notification filed by Conway Stuart Medical, Inc. with the FDA for Stretta Inflatable Basket Catheter Electrode With Aspiration.
| Device ID | K991291 |
| 510k Number | K991291 |
| Device Name: | STRETTA INFLATABLE BASKET CATHETER ELECTRODE WITH ASPIRATION |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | CONWAY STUART MEDICAL, INC. 735 PALOMAR ST. Sunnyvale, CA 94086 |
| Contact | David A Tucker |
| Correspondent | David A Tucker CONWAY STUART MEDICAL, INC. 735 PALOMAR ST. Sunnyvale, CA 94086 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-15 |
| Decision Date | 1999-07-14 |