CARDIOPLEGIC SETS
FDA 510(k) clearance K802545 · decided 1981-01-16
Clearance details
- K-number
- K802545
- Device name
- CARDIOPLEGIC SETS
- Applicant
- Texas Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-15
- Decision date
- 1981-01-16
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- DTR
- Device class
- 2
- Regulation number
- 870.4240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, 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.