The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Pull-apart Introducer (sheath).
| Device ID | K873727 |
| 510k Number | K873727 |
| Device Name: | PULL-APART INTRODUCER (SHEATH) |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-09 |
| Decision Date | 1987-10-07 |