R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005
FDA 510(k) clearance K071361 · decided 2007-08-20
Clearance details
- K-number
- K071361
- Device name
- R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005
- Applicant
- R4 Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-05-15
- Decision date
- 2007-08-20
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Paul, MN, 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.