The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modified Peel-away Introducer Set Line.
| Device ID | K864352 |
| 510k Number | K864352 |
| Device Name: | MODIFIED PEEL-AWAY INTRODUCER SET LINE |
| Classification | Introducer, Catheter |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Donald Andersen |
| Correspondent | Donald Andersen QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-04 |
| Decision Date | 1987-01-06 |