The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for Quest Vessel Catheter.
| Device ID | K971928 |
| 510k Number | K971928 |
| Device Name: | QUEST VESSEL CATHETER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes QUEST MEDICAL, INC. ONE ALLENTOWN PKWY. Allen, TX 75002 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-27 |
| Decision Date | 1997-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20634624533039 | K971928 | 000 |