The following data is part of a premarket notification filed by Cardiacassist Inc. with the FDA for Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set.
| Device ID | K162181 |
| 510k Number | K162181 |
| Device Name: | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh, PA 15238 |
| Contact | Greg Johnson |
| Correspondent | Greg Johnson CARDIACASSIST INC. 240 ALPHA DRIVE Pittsburgh, PA 15238 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-04 |
| Decision Date | 2017-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814112020463 | K162181 | 000 |
| 00814112020456 | K162181 | 000 |