The following data is part of a premarket notification filed by Vitalcor, Inc. with the FDA for Coronary Artery Perfusion Cannula With Self-inflating Balloon.
| Device ID | K030231 |
| 510k Number | K030231 |
| Device Name: | CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | VITALCOR, INC. 100 EAST CHESTNUT AVE. Westmont, IL 60559 |
| Contact | William Huck |
| Correspondent | William Huck VITALCOR, INC. 100 EAST CHESTNUT AVE. Westmont, IL 60559 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-22 |
| Decision Date | 2003-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10851321006090 | K030231 | 000 |
| 10851321006014 | K030231 | 000 |
| 10851321006021 | K030231 | 000 |
| 10851321006038 | K030231 | 000 |
| 10851321006045 | K030231 | 000 |
| 10851321006052 | K030231 | 000 |
| 10851321006069 | K030231 | 000 |
| 10851321006076 | K030231 | 000 |
| 10851321006083 | K030231 | 000 |
| 10851321006007 | K030231 | 000 |