The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Medtronic Clearview Intravascular Arteriotomy Shunt.
| Device ID | K993677 |
| 510k Number | K993677 |
| Device Name: | MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 620 WATSON STRET S.W. Grand Rapids, MI 49504 |
| Contact | Michael Hingson |
| Correspondent | Michael Hingson MEDTRONIC VASCULAR 620 WATSON STRET S.W. Grand Rapids, MI 49504 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-01 |
| Decision Date | 2000-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20885074257109 | K993677 | 000 |
| 20885074257475 | K993677 | 000 |