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FDA 510(k)

ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.

K-Number: K882289 · 1988-12-12

ApplicantAries Medical, Inc.
Decision Date1988-12-12
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. 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 1988-12-12 under 510(k) number K882289. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.?

ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. is a medical device that received FDA 510(k) clearance on 1988-12-12. The listed applicant is Aries Medical, Inc.. The 510(k) number is K882289.

When did ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. receive FDA 510(k) clearance?

ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. received FDA 510(k) clearance on 1988-12-12, under 510(k) number K882289.

Who is the listed applicant for ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.?

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 ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.?

The FDA product code for ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. is DSY.

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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. SYSK86499440CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETERK86453740CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER

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Related Devices (Code: DSY)

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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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