The following data is part of a premarket notification filed by Telectronics, Inc. with the FDA for Slim Art J. Bip Pacing Lead Using Poly #030-2821.
| Device ID | K852918 |
| 510k Number | K852918 |
| Device Name: | SLIM ART J. BIP PACING LEAD USING POLY #030-2821 |
| Classification | Introducer, Catheter |
| Applicant | TELECTRONICS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Contact | William C Nealon |
| Correspondent | William C Nealon TELECTRONICS, INC. 40 CRANE HILL RD. Suffield, CT 06078 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-24 |
| Decision Date | 1985-07-29 |