The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Merox Bipolar High Impedance Lead Models: Mex 53/13-bp; 60/15-bp; 45-jbp; 53-jbp.
| Device ID | K010281 |
| 510k Number | K010281 |
| Device Name: | MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-30 |
| Decision Date | 2002-04-09 |