The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Dorado Pta Balloon Dilatation Catheter.
Device ID | K072283 |
510k Number | K072283 |
Device Name: | DORADO PTA BALLOON DILATATION CATHETER |
Classification | Catheter, Percutaneous |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. Tempe, AZ 85281 |
Contact | Genevieve Balutowski |
Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
Product Code | DQY |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-08-16 |
Decision Date | 2007-09-19 |
Summary: | summary |