DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
FDA 510(k) clearance K091449 · decided 2009-06-18
Clearance details
- K-number
- K091449
- Device name
- DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
- Applicant
- Datascope Corp., Cardiac Assist Division
- Decision
- Substantially Equivalent
- Date received
- 2009-05-18
- Decision date
- 2009-06-18
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- DSP
- Device class
- 2
- Regulation number
- 870.3535
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fairfield, NJ, 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.