The following data is part of a premarket notification filed by Sorin Group Usa, Inc. with the FDA for Vascuclear Precision Bipolar.
| Device ID | K102983 |
| 510k Number | K102983 |
| Device Name: | VASCUCLEAR PRECISION BIPOLAR |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SORIN GROUP USA, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Scott Light |
| Correspondent | Scott Light SORIN GROUP USA, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-07 |
| Decision Date | 2010-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622132459 | K102983 | 000 |