The following data is part of a premarket notification filed by Shepherd Scientific Inc with the FDA for Docking Station,teirstein Edge,angioassist Combination Device, Angioassist Family.
| Device ID | K093822 |
| 510k Number | K093822 |
| Device Name: | DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY |
| Classification | Wire, Guide, Catheter |
| Applicant | SHEPHERD SCIENTIFIC INC 1515 COAST WALK La Jolla, CA 92037 |
| Contact | Paul Teirstein |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-12-14 |
| Decision Date | 2010-01-28 |
| Summary: | summary |