TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE
FDA 510(k) clearance K862722 · decided 1986-08-11
Clearance details
- K-number
- K862722
- Device name
- TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE
- Applicant
- Mercury Enterprises, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-17
- Decision date
- 1986-08-11
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- FKY
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Clearwater, FL, 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.
| Record | Firm | Date |
|---|---|---|
| PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI (K991003) | Dayspring Medical, Inc. | 1999-06-09 |
| CAPD COLOR-GUARD SYSTEM PREPKIT (K830002) | Abbott Laboratories | 1983-03-11 |
| TENCKHOFF PERITONEAL TUBING ADAPT. (K771428) | Quinton, Inc. | 1977-10-18 |
Recalls involving this device
No recalls on record reference this clearance.