The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Atlas Gold Pta Dilatation Catheter.
Device ID | K122984 |
510k Number | K122984 |
Device Name: | ATLAS GOLD PTA DILATATION CATHETER |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | C.R. BARD, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 -1740 |
Contact | Jennifer Logvin |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2012-09-26 |
Decision Date | 2012-10-22 |
Summary: | summary |