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FDA 510(k)

MODIFIED PEEL-AWAY INTRODUCER SET LINE

K-Number: K864352 · 1987-01-06

ApplicantQuinton, Inc.
Decision Date1987-01-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED PEEL-AWAY INTRODUCER SET LINE is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1987-01-06 under 510(k) number K864352. 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 MODIFIED PEEL-AWAY INTRODUCER SET LINE?

MODIFIED PEEL-AWAY INTRODUCER SET LINE is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is Quinton, Inc.. The 510(k) number is K864352.

When did MODIFIED PEEL-AWAY INTRODUCER SET LINE receive FDA 510(k) clearance?

MODIFIED PEEL-AWAY INTRODUCER SET LINE received FDA 510(k) clearance on 1987-01-06, under 510(k) number K864352.

Who is the listed applicant for MODIFIED PEEL-AWAY INTRODUCER SET LINE?

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

What is the FDA product code for MODIFIED PEEL-AWAY INTRODUCER SET LINE?

The FDA product code for MODIFIED PEEL-AWAY INTRODUCER SET LINE is DYB.

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Other records listing Quinton, Inc. as applicant

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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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