JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
FDA 510(k) clearance K092332 · decided 2009-09-03
Clearance details
- K-number
- K092332
- Device name
- JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
- Applicant
- Pathway Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-08-04
- Decision date
- 2009-09-03
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kirkland, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.