MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
FDA 510(k) clearance K030589 · decided 2003-05-21
Clearance details
- K-number
- K030589
- Device name
- MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
- Applicant
- NuMED, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-25
- Decision date
- 2003-05-21
- Days to decision
- 85 days
- Clearance type
- Special
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hopkinton, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.