UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO
FDA 510(k) clearance K861984 · decided 1986-08-05
Clearance details
- K-number
- K861984
- Device name
- UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO
- Applicant
- Universal Medical Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-22
- Decision date
- 1986-08-05
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ballston Spa, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.