GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
FDA 510(k) clearance K040301 · decided 2004-11-01
Clearance details
- K-number
- K040301
- Device name
- GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A
- Applicant
- Gambro Renal Products
- Decision
- Unknown
- Date received
- 2004-02-09
- Decision date
- 2004-11-01
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- MPB
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.