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FDA 510(k)

MORSE HEMOSTATIC CATHETER INTRODUCER SET

K-Number: K915078 · 1992-06-10

ApplicantNorth American Instrument Corp.
Decision Date1992-06-10
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MORSE HEMOSTATIC CATHETER INTRODUCER SET 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 1992-06-10 under 510(k) number K915078. 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 MORSE HEMOSTATIC CATHETER INTRODUCER SET?

MORSE HEMOSTATIC CATHETER INTRODUCER SET is a medical device that received FDA 510(k) clearance on 1992-06-10. The listed applicant is North American Instrument Corp.. The 510(k) number is K915078.

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

MORSE HEMOSTATIC CATHETER INTRODUCER SET received FDA 510(k) clearance on 1992-06-10, under 510(k) number K915078.

Who is the listed applicant for MORSE HEMOSTATIC CATHETER INTRODUCER SET?

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 MORSE HEMOSTATIC CATHETER INTRODUCER SET?

The FDA product code for MORSE HEMOSTATIC CATHETER INTRODUCER SET 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-VALVEK960310EPIC INTRODUCER SHEATHK922552MORSE(R) ANGIOGRAPHIC CATHETERSK905208MORSE 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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