A1-CS-SB Y-ADAPTER, MODEL 124 871
FDA 510(k) clearance K003454 · decided 2001-01-18
Clearance details
- K-number
- K003454
- Device name
- A1-CS-SB Y-ADAPTER, MODEL 124 871
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 2000-11-07
- Decision date
- 2001-01-18
- Days to decision
- 72 days
- Clearance type
- Special
- Product code
- DTD
- Device class
- 2
- Regulation number
- 870.3620
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biotronik
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.