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510(k) K810530

PERI-PATCH GLUE MOLD by Quinton, Inc. — Product Code KGZ

K810530 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "PERI-PATCH GLUE MOLD". The FDA issued a decision of Substantially Equivalent on March 24, 1981. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. Quinton, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1981
Date Received
February 26, 1981
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 Quinton, Inc.

  • K032038 — PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 (September 5, 2003)
  • K021906 — QUINTON Q-CATH, MODEL 000460 (September 4, 2002)
  • K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 (January 25, 2001)
  • K001492 — QUINTON Q-STRESS, MODEL 000483 (August 9, 2000)
  • K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) (March 6, 2000)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K971397 — VIEWCATH 3-D CATHETER PULLBACK (August 25, 1997)
  • K964784 — SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) (August 13, 1997)
  • K964978 — VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) (May 21, 1997)
  • K955002 — MAHURKAR 8 FR DUAL LEMEN CATHETER (September 13, 1996)

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)
  • K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET (November 3, 1989)
  • 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)

FDA data resources