The following data is part of a premarket notification filed by Teleflex, Inc. with the FDA for Modified Teleflex Medical Introducer Catheter.
| Device ID | K861951 |
| 510k Number | K861951 |
| Device Name: | MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER |
| Classification | Introducer, Catheter |
| Applicant | TELEFLEX, INC. TALL PINES PARK Jeffrey, NH 03452 |
| Contact | Gary C Bullard |
| Correspondent | Gary C Bullard TELEFLEX, INC. TALL PINES PARK Jeffrey, NH 03452 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-19 |