The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modification (material Change) Of Peel-away Sheath.
| Device ID | K864705 |
| 510k Number | K864705 |
| Device Name: | MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH |
| Classification | Introducer, Catheter |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Randy Walls |
| Correspondent | Randy Walls 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 | 1986-12-02 |
| Decision Date | 1987-02-13 |