SLIDEWIRETM(TRADEMARK PENDING)
FDA 510(k) clearance K113162 · decided 2012-07-20
Clearance details
- K-number
- K113162
- Device name
- SLIDEWIRETM(TRADEMARK PENDING)
- Applicant
- Acme-Monaco Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-26
- Decision date
- 2012-07-20
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- New Britain, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.