Home / 510(k) Clearances / K861483

510(k) K861483

ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY) by Mallinckrodt Critical Care — Product Code DQO

K861483 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "ANGIOGRAPHIC CATHETER (CARDIOLOGY & RADIOLOGY)". The FDA issued a decision of Substantially Equivalent on May 15, 1986. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1986
Date Received
April 17, 1986
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 Mallinckrodt Critical Care

  • K880343 — BURNEY GALLBLADDER CATHETER KIT (May 1, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE (January 29, 1988)
  • K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (January 6, 1988)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (November 6, 1987)
  • K873833 — THERMOCOUPLE ADAPTER (November 3, 1987)
  • K873004 — GUIDING CATHETER (September 15, 1987)
  • K871204 — CUFFED TRACHEAL TUBE (MULTIPLE) (April 21, 1987)
  • K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (August 1, 1986)

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