Home / 510(k) Clearances / K923603

510(k) K923603

INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION by Kontron Instruments, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1993
Date Received
July 2, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Kontron Instruments, Inc.

  • K971038 — KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE (September 24, 1997)
  • K932268 — MODIFICATIONS TO INTRA-AORTIC BALLOONS (December 15, 1993)
  • K925248 — MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS (September 27, 1993)
  • K905313 — KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II (June 19, 1991)
  • K903344 — 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) (January 15, 1991)
  • K896437 — KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM (December 3, 1990)
  • K892222 — 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON (September 14, 1990)
  • K882955 — SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 (January 26, 1990)
  • K896386 — MINIMON 7133B PATIENT MONITOR (December 13, 1989)
  • K896417 — KONTRON KOLORMON 7250 PATIENT MONITOR (December 12, 1989)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)