BALLOON CATHETER
FDA 510(k) clearance K810689 · decided 1981-07-28
Clearance details
- K-number
- K810689
- Device name
- BALLOON CATHETER
- Applicant
- Surgimed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-13
- Decision date
- 1981-07-28
- Days to decision
- 137 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.