PERITONEAL DIALYSIS CATHETERS
FDA 510(k) clearance K863128 · decided 1986-09-09
Clearance details
- K-number
- K863128
- Device name
- PERITONEAL DIALYSIS CATHETERS
- Applicant
- Thermedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-15
- Decision date
- 1986-09-09
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- FJS
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.