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510(k) K901336

ASI HEMOSTASIS CATHETER by Advanced Surgical Intervention, Inc. — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1990
Date Received
March 22, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethral
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Advanced Surgical Intervention, Inc.

  • K954215 — MINIGUARD (May 8, 1996)
  • K926110 — ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT (July 8, 1993)
  • K930361 — ASI CYSTOLASE LASER CYSTOSCOPE (April 29, 1993)
  • K921990 — ASI UROPLASTY LASER CYSTOSCOPE (October 28, 1992)
  • K902585 — UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER (August 27, 1990)
  • K896713 — ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. (May 24, 1990)
  • K895182 — ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY (October 24, 1989)
  • K874530 — URETHRAL DILATOR ENDOSCOPE (January 27, 1988)

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