The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Vp Sheath.
| Device ID | K051580 |
| 510k Number | K051580 |
| Device Name: | VP SHEATH |
| Classification | Catheter, Percutaneous |
| Applicant | FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale, CA 94085 |
| Contact | Richard Spano |
| Correspondent | Richard Spano FLOWCARDIA, INC. 745 N. PASTORIA AVE. Sunnyvale, CA 94085 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-15 |
| Decision Date | 2005-10-31 |