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510(k) K896087

PALESTRANT IRRIGATION AND DRAINAGE SET by North American Instrument Corp. — Product Code KGZ

K896087 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "PALESTRANT IRRIGATION AND DRAINAGE SET". The FDA issued a decision of Substantially Equivalent on November 3, 1989. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. North American Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1989
Date Received
October 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by North American Instrument Corp.

  • K960801 — SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) (March 29, 1996)
  • K955554 — HEMO-VALVE (March 4, 1996)
  • K960310 — EPIC INTRODUCER SHEATH (February 7, 1996)
  • K922552 — MORSE(R) ANGIOGRAPHIC CATHETERS (March 3, 1993)
  • K915078 — MORSE HEMOSTATIC CATHETER INTRODUCER SET (June 10, 1992)
  • K905208 — MORSE ANESTHESIA (January 10, 1992)
  • K912961 — MORSE VASCULAR INTRODUCER SET (September 11, 1991)
  • K910764 — THE PERCEPTOR(TM) STAND ALONE TRANSDUCER (April 22, 1991)
  • K903493 — NAMIC CONTRAST SAVINGS DELIVERY SYSTEM (March 26, 1991)
  • K904275 — MORSE BALLOON INFLATION DEVICE (January 3, 1991)

Other clearances for product code KGZ

  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973183 — WOUND DRAINAGE HOLDER (January 23, 1998)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K895041 — OPTICAL CATHETER(TM) INTRODUCER SETS (October 16, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K873009 — CONCEPT SWITCHING STICK (August 17, 1987)
  • K870014 — HCI GENERAL PURPOSE CATHETER STYLET (February 6, 1987)
  • K864115 — TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU (November 7, 1986)

FDA data resources