MULTIPACE
FDA 510(k) clearance K934785 · decided 1995-07-27
Clearance details
- K-number
- K934785
- Device name
- MULTIPACE
- Applicant
- Electro-Catheter Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-05
- Decision date
- 1995-07-27
- Days to decision
- 660 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rahway, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.