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 |