Home / 510(k) Clearances / K960965

510(k) K960965

FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 by Coeur Laboratories, Inc. — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1996
Date Received
March 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Coeur Laboratories, Inc.

  • K971712 — COEUR 130 ML ANGIOGRAPHIC SYRINGE (October 8, 1997)
  • K965214 — COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (March 28, 1997)
  • K890292 — PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE (June 22, 1989)
  • K885138 — CAPILLARY TUBE, BLOOD COLLECTION (February 7, 1989)
  • K885202 — 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR (January 31, 1989)
  • K881646 — UROLOGICAL CATHETER (June 16, 1988)
  • K874579 — COEUR CONTROL SYRINGE (January 19, 1988)
  • K873597 — TUBING, POLYETHYLENE (November 12, 1987)
  • K823920 — COEURLOCK STERILE DISPOS. ANGIOGRAPHIC (February 18, 1983)

Other clearances for product code DXT

  • K251788 — Extension tube (March 5, 2026)
  • K252891 — MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD (February 13, 2026)
  • K244038 — High Pressure Tubing (September 5, 2025)
  • K242143 — Angiography Injector (December 23, 2024)
  • K242212 — Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (August 27, 2024)
  • K241109 — Single-use Sterile High-pressure Angiographic Syringes and Accessories (August 22, 2024)
  • K230668 — Disposable High-pressure Extension Lines (June 14, 2024)
  • K232388 — High Pressure Tubing (November 21, 2023)
  • K211564 — Sterile High-pressure Angiographic Syringes for Single-use (October 19, 2021)
  • K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (December 17, 2020)