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FDA 510(k)

40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER

K-Number: K864537 · 1987-06-19

ApplicantAries Medical, Inc.
Decision Date1987-06-19
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Aries Medical, Inc.. It received FDA 510(k) clearance on 1987-06-19 under 510(k) number K864537. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER?

40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1987-06-19. The listed applicant is Aries Medical, Inc.. The 510(k) number is K864537.

When did 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER receive FDA 510(k) clearance?

40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER received FDA 510(k) clearance on 1987-06-19, under 510(k) number K864537.

Who is the listed applicant for 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER?

The FDA 510(k) record lists Aries Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER?

The FDA product code for 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER is DSP.

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Other records listing Aries Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K912604SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIFK903925ARIES MELDICAL MODEL 2100HC HANK CRANKK903442ARIES TAPERSEAL(TM) SHEATHK895433ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYSK882289ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.K86499440CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER

View all 19 devices →

Related Devices (Code: DSP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLCK232343AC3™ Series IABPArrow International, LLCK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, TeleflexK190101UltraFlex IABArrow International, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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