RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000— 510(k) K981083
Substantially Equivalent - Subject to Tracking Reg.Biotronik, Inc.
FDA 510(k) clearance K981083 for RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000, Substantially Equivalent - Subject to Tracking Reg. on 1998-07-22. Applicant: Biotronik, Inc.. Device class: 3.
Clearance details
- Applicant
- Biotronik, Inc.
- Product code
- Code DTB
- Device class
- Class 3
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Lake Oswego, OR, US
Recent devices under product code DTB
view allMore clearances from Biotronik, Inc.
view allAdverse events under product code DTB
product code DTB- Death
- 1,491
- Injury
- 67,311
- Malfunction
- 79,368
- Other
- 10
- Total
- 148,180
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.