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510(k) K931560

CARDIAC CATHETERIZATION TRAY by Clinipad Corp. — Product Code DQO

K931560 is an FDA 510(k) premarket notification submitted by Clinipad Corp. for the device "CARDIAC CATHETERIZATION TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 11, 1994. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Clinipad Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
July 11, 1994
Date Received
March 30, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Clinipad Corp.

  • K931668 — PICC INSERTION TRAY (March 7, 1994)
  • K932071 — I.V. START KIT (February 17, 1994)
  • K932010 — V.A.D. ACCESS KIT (February 3, 1994)
  • K932036 — LACERATION TRAY (December 13, 1993)
  • K932016 — TRACHEOSTOMY CARE TRAY (November 3, 1993)
  • K862562 — PUNCH BIOPSY KIT (October 7, 1986)
  • K862563 — TRACHEOSTOMY CLEANSING SOLUTION (July 15, 1986)
  • K833075 — WET DRESSING KIT (January 27, 1984)
  • K833432 — CATHETER INSERTION KIT (December 28, 1983)
  • K830476 — OR PREP KIT (March 31, 1983)

Other clearances for product code DQO

  • K261455 — Arterial Pressure Monitoring Set/Tray (June 26, 2026)
  • K252702 — Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, (May 28, 2026)
  • K254278 — Arterial Pressure Monitoring Set/Tray (March 25, 2026)
  • K250751 — DualView Catheter (July 17, 2025)
  • K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (January 31, 2025)
  • K242420 — pNOVUS 21 Microcatheter (November 12, 2024)
  • K233268 — Impress Angiographic Catheter (May 22, 2024)
  • K233975 — Zoom 6F Insert Catheters (April 2, 2024)
  • K232536 — Soldier Microcatheter (February 23, 2024)
  • K232573 — INFINITI™ Ambi Angiographic Catheter (November 21, 2023)

FDA data resources