The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci Commander Series Guide Wires.
Device ID | K961271 |
510k Number | K961271 |
Device Name: | USCI COMMANDER SERIES GUIDE WIRES |
Classification | Wire, Guide, Catheter |
Applicant | C.R. BARD, INC. 129 CONCORD RD. Billerica, MA 01821 -7031 |
Contact | Deborah L Herrington |
Correspondent | Deborah L Herrington C.R. BARD, INC. 129 CONCORD RD. Billerica, MA 01821 -7031 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-02 |
Decision Date | 1996-06-27 |
Summary: | summary |