DISPOSABLE TEMPORARY PACING WIRE
FDA 510(k) clearance K023174 · decided 2003-06-11
Clearance details
- K-number
- K023174
- Device name
- DISPOSABLE TEMPORARY PACING WIRE
- Applicant
- River Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-23
- Decision date
- 2003-06-11
- Days to decision
- 261 days
- Clearance type
- Traditional
- Product code
- LDF
- Device class
- 2
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.