The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Modification Of Tissue Dilator.
| Device ID | K862288 |
| 510k Number | K862288 |
| Device Name: | MODIFICATION OF TISSUE DILATOR |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Contact | Donald L Andersen |
| Correspondent | Donald L Andersen QUINTON, INC. 2121 TERRY AVE. Seatle, WA 98121 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-16 |
| Decision Date | 1986-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521004006 | K862288 | 000 |
| 20884521003993 | K862288 | 000 |