Atlas FDA

TUBING, DIALYSATE (AND CONNECTOR)

FDA 510(k) clearance K022068 · decided 2002-09-23

Clearance details

K-number
K022068
Device name
TUBING, DIALYSATE (AND CONNECTOR)
Applicant
Molded Products, Inc.
Decision
Substantially Equivalent
Date received
2002-06-25
Decision date
2002-09-23
Days to decision
90 days
Clearance type
Traditional
Product code
FID
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Harlan, IA, 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.

RecordFirmDate
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES (K010712)Molded Products, Inc.2001-09-27
TYGON M-60/TYGON M-70 (K770299)Norton Performance Plastics Corp.1977-03-16

Recalls involving this device

No recalls on record reference this clearance.