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510(k) K854512

TUBING CLAMP CAT#1000-A by Rao Medical Devices, Inc. — Product Code FKK

K854512 is an FDA 510(k) premarket notification submitted by Rao Medical Devices, Inc. for the device "TUBING CLAMP CAT#1000-A". The FDA issued a decision of Substantially Equivalent on December 2, 1985. The device falls under product code FKK (Clamp, Line), a Class I device regulated under 21 CFR 876.4730. Rao Medical Devices, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1985
Date Received
November 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Line
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Rao Medical Devices, Inc.

  • K854965 — IN LINE VALVE CATALOG NO. 2000A (February 21, 1986)

Other clearances for product code FKK

  • K854517 — NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET (December 2, 1985)
  • K844121 — CLAMP, TUBING, LINE (December 17, 1984)
  • K831689 — EMPTY DIALYSATE CONTAINER (August 11, 1983)
  • K822551 — AMP CAPD UNISPIKE AMINISTRATION SET (October 13, 1982)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)

FDA data resources