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FDA 510(k)

ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV

K-Number: K861238 · 1986-07-16

ApplicantAngiomedics, Inc.
Decision Date1986-07-16
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV is the device name listed in this FDA 510(k) record. The listed applicant is Angiomedics, Inc.. It received FDA 510(k) clearance on 1986-07-16 under 510(k) number K861238. 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 ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV?

ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV is a medical device that received FDA 510(k) clearance on 1986-07-16. The listed applicant is Angiomedics, Inc.. The 510(k) number is K861238.

When did ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV receive FDA 510(k) clearance?

ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV received FDA 510(k) clearance on 1986-07-16, under 510(k) number K861238.

Who is the listed applicant for ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV?

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

What is the FDA product code for ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV?

The FDA product code for ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV is DYB.

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Other records listing Angiomedics, 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.

K873195SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMOK872472SCHNEIDER-SHILEY BIFLATOR BALLOON INFLATION DEVICEK872542SCHNEIDER-SHILEY SOFTRAC-PTA(TM) ANGIO. CATHETERK863342SOFTIP CORONARY SINUS CARDIOPLEGIA CATHETERK852872ANGIOMEDICS SOFTIP CATHETERK850271ANGIOMEDIC'S CATHETER-DIAGNOSTIC INTRAVASCULAR

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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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