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 |