The following data is part of a premarket notification filed by Telectronics Pacing Systems, Inc. with the FDA for New Lead Introducer Kits, Various Models.
| Device ID | K926340 |
| 510k Number | K926340 |
| Device Name: | NEW LEAD INTRODUCER KITS, VARIOUS MODELS |
| Classification | Introducer, Catheter |
| Applicant | TELECTRONICS PACING SYSTEMS, INC. C/O RICHARD S. MOREY 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Contact | Candace F Howell |
| Correspondent | Candace F Howell TELECTRONICS PACING SYSTEMS, INC. C/O RICHARD S. MOREY 1140 NINETEENTH STREET, N.W. Washington, DC 20036 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-17 |
| Decision Date | 1993-05-27 |