The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Arterial Embolectomy Catheter.
| Device ID | K901627 |
| 510k Number | K901627 |
| Device Name: | ARTERIAL EMBOLECTOMY CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Contact | Robert P Cooper |
| Correspondent | Robert P Cooper APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-09 |
| Decision Date | 1990-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663109692 | K901627 | 000 |
| 00840663109685 | K901627 | 000 |
| 00840663109661 | K901627 | 000 |
| 00840663109654 | K901627 | 000 |
| 00840663109647 | K901627 | 000 |
| 00840663109630 | K901627 | 000 |
| 00840663109623 | K901627 | 000 |
| 00840663109616 | K901627 | 000 |