The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Permcath Insertion Tray.
| Device ID | K874633 |
| 510k Number | K874633 |
| Device Name: | PERMCATH INSERTION TRAY |
| Classification | Catheter, Subclavian |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Ron R Duck |
| Correspondent | Ron R Duck QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | LFJ |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1988-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521009919 | K874633 | 000 |
| 20884521009858 | K874633 | 000 |
| 20884521009841 | K874633 | 000 |
| 10884521009899 | K874633 | 000 |