Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
FDA 510(k) clearance K150046 · decided 2015-10-30
Clearance details
- K-number
- K150046
- Device name
- Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
- Applicant
- Zoll Circulation, Inc.
- Decision
- Unknown
- Date received
- 2015-01-12
- Decision date
- 2015-10-30
- Days to decision
- 291 days
- Clearance type
- Traditional
- Product code
- NCX
- Device class
- 2
- Regulation number
- 870.5900
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
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