The following data is part of a premarket notification filed by Advanced Surgical Intervention, Inc. with the FDA for Asi Hemostasis Catheter.
| Device ID | K901336 |
| 510k Number | K901336 |
| Device Name: | ASI HEMOSTASIS CATHETER |
| Classification | Catheter, Urethral |
| Applicant | ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Contact | M Calvarese,ms |
| Correspondent | M Calvarese,ms ADVANCED SURGICAL INTERVENTION, INC. 951 CALLE AMANECER San Clemente, CA 92672 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-22 |
| Decision Date | 1990-06-20 |