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FDA 510(k)

ARIES TAPERSEAL(TM) SHEATH

K-Number: K903442 · 1990-08-23

ApplicantAries Medical, Inc.
Decision Date1990-08-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARIES TAPERSEAL(TM) SHEATH 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 1990-08-23 under 510(k) number K903442. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIES TAPERSEAL(TM) SHEATH?

ARIES TAPERSEAL(TM) SHEATH is a medical device that received FDA 510(k) clearance on 1990-08-23. The listed applicant is Aries Medical, Inc.. The 510(k) number is K903442.

When did ARIES TAPERSEAL(TM) SHEATH receive FDA 510(k) clearance?

ARIES TAPERSEAL(TM) SHEATH received FDA 510(k) clearance on 1990-08-23, under 510(k) number K903442.

Who is the listed applicant for ARIES TAPERSEAL(TM) SHEATH?

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 TAPERSEAL(TM) SHEATH?

The FDA product code for ARIES TAPERSEAL(TM) SHEATH is DYB.

Related Clinical Trials

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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 CRANKK895433ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYSK882289ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.K86499440CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETERK86453740CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER

View all 19 devices →

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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