The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for A1-cs-sb Y-adapter, Model 124 871.
| Device ID | K003454 |
| 510k Number | K003454 |
| Device Name: | A1-CS-SB Y-ADAPTER, MODEL 124 871 |
| Classification | Pacemaker Lead Adaptor |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Jon Burmbaugh |
| Correspondent | Jon Burmbaugh BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTD |
| CFR Regulation Number | 870.3620 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-07 |
| Decision Date | 2001-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04035479012816 | K003454 | 000 |