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510(k) K864537

40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER by Aries Medical, Inc. — Product Code DSP

K864537 is an FDA 510(k) premarket notification submitted by Aries Medical, Inc. for the device "40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER". The FDA issued a decision of Substantially Equivalent on June 19, 1987. The device falls under product code DSP (System, Balloon, Intra-Aortic And Control), a Class II device regulated under 21 CFR 870.3535. Aries Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1987
Date Received
November 17, 1986
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 Aries Medical, Inc.

  • K912604 — SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF (October 28, 1991)
  • K903925 — ARIES MELDICAL MODEL 2100HC HANK CRANK (December 21, 1990)
  • K903442 — ARIES TAPERSEAL(TM) SHEATH (August 23, 1990)
  • K895433 — ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS (April 10, 1990)
  • K882289 — ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. (December 12, 1988)
  • K864994 — 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER (June 19, 1987)
  • K864568 — 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER (May 12, 1987)
  • K864567 — 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER (May 12, 1987)
  • K871140 — ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER (April 22, 1987)
  • K870189 — ARIES TAPERED SHEATH (March 16, 1987)

Other clearances for product code DSP

  • K250542 — AC3™ Range™ Intra-Aortic Balloon Pump (March 26, 2025)
  • K232343 — AC3™ Series IABP (August 30, 2023)
  • K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (May 27, 2020)
  • K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (April 9, 2020)
  • K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP) (November 12, 2019)
  • K190101 — UltraFlex IAB (June 28, 2019)
  • K190117 — Fiberoptix IAB (June 13, 2019)
  • K181122 — CARDIOSAVE Intra-Aortic Balloon Pump (May 31, 2018)
  • K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (October 12, 2017)
  • K162820 — AC3 Series IABP System (March 31, 2017)

FDA data resources