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FDA 510(k)

EPIC INTRODUCER SHEATH

K-Number: K960310 · 1996-02-07

ApplicantNorth American Instrument Corp.
Decision Date1996-02-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPIC INTRODUCER SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is North American Instrument Corp.. It received FDA 510(k) clearance on 1996-02-07 under 510(k) number K960310. 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 EPIC INTRODUCER SHEATH?

EPIC INTRODUCER SHEATH is a medical device that received FDA 510(k) clearance on 1996-02-07. The listed applicant is North American Instrument Corp.. The 510(k) number is K960310.

When did EPIC INTRODUCER SHEATH receive FDA 510(k) clearance?

EPIC INTRODUCER SHEATH received FDA 510(k) clearance on 1996-02-07, under 510(k) number K960310.

Who is the listed applicant for EPIC INTRODUCER SHEATH?

The FDA 510(k) record lists North American Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPIC INTRODUCER SHEATH?

The FDA product code for EPIC INTRODUCER SHEATH is DYB.

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Other records listing North American Instrument Corp. 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.

K960801SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)K955554HEMO-VALVEK922552MORSE(R) ANGIOGRAPHIC CATHETERSK915078MORSE HEMOSTATIC CATHETER INTRODUCER SETK905208MORSE ANESTHESIAK912961MORSE VASCULAR INTRODUCER SET

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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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