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FDA 510(k)

PERCUTANEOUS CATHETER INTRODUCER SET

K-Number: K842004 · 1984-07-13

ApplicantAries Medical, Inc.
Decision Date1984-07-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS CATHETER INTRODUCER SET 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 1984-07-13 under 510(k) number K842004. 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 PERCUTANEOUS CATHETER INTRODUCER SET?

PERCUTANEOUS CATHETER INTRODUCER SET is a medical device that received FDA 510(k) clearance on 1984-07-13. The listed applicant is Aries Medical, Inc.. The 510(k) number is K842004.

When did PERCUTANEOUS CATHETER INTRODUCER SET receive FDA 510(k) clearance?

PERCUTANEOUS CATHETER INTRODUCER SET received FDA 510(k) clearance on 1984-07-13, under 510(k) number K842004.

Who is the listed applicant for PERCUTANEOUS CATHETER INTRODUCER SET?

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 PERCUTANEOUS CATHETER INTRODUCER SET?

The FDA product code for PERCUTANEOUS CATHETER INTRODUCER SET is DYB.

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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

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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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