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510(k) K925248

MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS by Kontron Instruments, Inc. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1993
Date Received
October 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Balloon, Intra-Aortic And Control
Device Class
Class II
Regulation Number
870.3535
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)
  • K923603 — INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION (March 8, 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)

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