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510(k) K911215

GESCO PER-Q-CATH NEEDLE by Gesco Intl., Inc. — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1991
Date Received
March 19, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Gesco Intl., Inc.

  • K954422 — PER-Q-CATH MID-LINE (December 15, 1995)
  • K940953 — UMBILI-CATH-S (August 2, 1994)
  • K940870 — UMBILI-CATH (August 2, 1994)
  • K940952 — UMBILI-CATH-S-DL (July 29, 1994)
  • K941672 — URI-CATH CATHETER (May 16, 1994)
  • K941232 — THORA-CATH (May 11, 1994)
  • K940871 — UMBILI-CATH-P (April 29, 1994)
  • K931989 — VENTRI-CATH (July 21, 1993)
  • K926063 — PER-Q-CATH DRESSING CHANGE TRAY (June 7, 1993)
  • K923591 — PALA-NATE (March 16, 1993)

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