The following data is part of a premarket notification filed by Telectronics Pacing Systems, Inc. with the FDA for Upsizing Lead Adapters 5.0mm Peel-away Adapter.
Device ID | K896438 |
510k Number | K896438 |
Device Name: | UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER |
Classification | Pacemaker Lead Adaptor |
Applicant | TELECTRONICS PACING SYSTEMS, INC. 7400 SOUTH TUCSON WAY Englewood, CO 80112 |
Contact | Duane A Schultz |
Correspondent | Duane A Schultz TELECTRONICS PACING SYSTEMS, INC. 7400 SOUTH TUCSON WAY Englewood, CO 80112 |
Product Code | DTD |
CFR Regulation Number | 870.3620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-09 |
Decision Date | 1990-04-10 |