The following data is part of a premarket notification filed by Angiotech Pharmaceuticals, Inc. with the FDA for Angiotech Cvc.
| Device ID | K073520 |
| 510k Number | K073520 |
| Device Name: | ANGIOTECH CVC |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | ANGIOTECH PHARMACEUTICALS, INC. 13921 PARK CENTER ROAD SUITE 100 Herndon, VA 20171 |
| Contact | Trudy D Estridge |
| Correspondent | Trudy D Estridge ANGIOTECH PHARMACEUTICALS, INC. 13921 PARK CENTER ROAD SUITE 100 Herndon, VA 20171 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-12-14 |
| Decision Date | 2008-04-11 |
| Summary: | summary |