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FDA 510(k)

INTHERM RADIALLY EXPANDING DILATING INTRODUCER

K-Number: K931489 · 1993-10-15

ApplicantInnerdyne Medical, Inc.
Decision Date1993-10-15
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTHERM RADIALLY EXPANDING DILATING INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Innerdyne Medical, Inc.. It received FDA 510(k) clearance on 1993-10-15 under 510(k) number K931489. 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 INTHERM RADIALLY EXPANDING DILATING INTRODUCER?

INTHERM RADIALLY EXPANDING DILATING INTRODUCER is a medical device that received FDA 510(k) clearance on 1993-10-15. The listed applicant is Innerdyne Medical, Inc.. The 510(k) number is K931489.

When did INTHERM RADIALLY EXPANDING DILATING INTRODUCER receive FDA 510(k) clearance?

INTHERM RADIALLY EXPANDING DILATING INTRODUCER received FDA 510(k) clearance on 1993-10-15, under 510(k) number K931489.

Who is the listed applicant for INTHERM RADIALLY EXPANDING DILATING INTRODUCER?

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

What is the FDA product code for INTHERM RADIALLY EXPANDING DILATING INTRODUCER?

The FDA product code for INTHERM RADIALLY EXPANDING DILATING INTRODUCER is DYB.

Related Clinical Trials

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Other records listing Innerdyne 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.

K943253INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.K943056SINGLE STICK RADIALLY EXPANDING DILATORK940428INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATORK940232INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.K932692INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT

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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