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510(k) K813335

PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY by American Pharmaseal Div. Ahsc — Product Code FSH

K813335 is an FDA 510(k) premarket notification submitted by American Pharmaseal Div. Ahsc for the device "PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY". The FDA issued a decision of Substantially Equivalent on January 8, 1982. The device falls under product code FSH (Tray, Surgical, Needle), a Class I device regulated under 21 CFR 878.4800. American Pharmaseal Div. Ahsc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1982
Date Received
November 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical, Needle
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by American Pharmaseal Div. Ahsc

  • K874022 — PHARMASEAL WOUND IRRIGATION DEVICE (December 30, 1987)
  • K874517 — PHARMASEAL RUBBER URETHRAL CATHETER (December 3, 1987)
  • K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER (December 3, 1987)
  • K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE (November 6, 1987)
  • K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM (September 4, 1987)
  • K872917 — JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER (August 11, 1987)
  • K871429 — ANTIMICROBIAL FOLEY CATHETER (August 10, 1987)
  • K871770 — AMERICAN PHARMASEAL WOUND DRESSING (June 26, 1987)
  • K870387 — EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE (May 8, 1987)
  • K870977 — PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE (April 1, 1987)

Other clearances for product code FSH

  • K884876 — S 4 INSTRUMENT STAND (December 15, 1988)
  • K883578 — S 21 INSTRUMENT STAND (September 13, 1988)
  • K821921 — STAND, SURG. INSTRUMENT & DRESSING (July 30, 1982)
  • K813338 — BIOPSY NEEDLES & TRAYS (January 28, 1982)
  • K813337 — SKINNY CHIBA NEEDLE & TRAY (January 28, 1982)
  • K780759 — MODEL 902 STAND (May 19, 1978)
  • K772188 — FSH RIA KIT (125I) (December 22, 1977)

FDA data resources