The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Input 10f/11/f Introducer Set(010101(10f), 011101(11f).
| Device ID | K961135 |
| 510k Number | K961135 |
| Device Name: | INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F) |
| Classification | Introducer, Catheter |
| Applicant | C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Contact | Robert T Miragliuolo |
| Correspondent | Robert T Miragliuolo C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-21 |
| Decision Date | 1996-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169014439 | K961135 | 000 |
| 20643169014422 | K961135 | 000 |