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510(k) K822551

AMP CAPD UNISPIKE AMINISTRATION SET by American Medical Products, Inc. — Product Code FKK

K822551 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "AMP CAPD UNISPIKE AMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on October 13, 1982. The device falls under product code FKK (Clamp, Line), a Class I device regulated under 21 CFR 876.4730. American Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1982
Date Received
August 24, 1982
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 American Medical Products, Inc.

  • K922290 — SINGLE-STEP PREGNANCY, HCG TEST (July 9, 1992)
  • K862221 — E-Z CLEAN (September 12, 1986)
  • K861251 — AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N (April 17, 1986)
  • K830881 — AMPERCIDE DISINFECTANT ACCESSORY TO - (June 2, 1983)
  • K823827 — AMP 80/2 OUTFLOW MONITOR MODIFICATION (March 17, 1983)
  • K822543 — CAPD SAFE LOCK TRANSFER SET (October 13, 1982)
  • K822549 — CCPD CYCLER SET W/5 PRONGED SAFE LOCK (October 13, 1982)
  • K822546 — SAFE LOCK SEALING CAPS (October 13, 1982)
  • K822548 — SAFE LOCK CATHETER S-3 (October 13, 1982)
  • K822545 — CCPD CYCLER SET W/5 PRONGED CONNECTOR (October 13, 1982)

Other clearances for product code FKK

  • K854512 — TUBING CLAMP CAT#1000-A (December 2, 1985)
  • 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)
  • K802009 — FLOWCLAMP CAT.#1011 & 1012 (October 31, 1980)

FDA data resources