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FDA 510(k)

MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH

K-Number: K864705 · 1987-02-13

ApplicantQuinton, Inc.
Decision Date1987-02-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1987-02-13 under 510(k) number K864705. 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 MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH?

MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH is a medical device that received FDA 510(k) clearance on 1987-02-13. The listed applicant is Quinton, Inc.. The 510(k) number is K864705.

When did MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH receive FDA 510(k) clearance?

MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH received FDA 510(k) clearance on 1987-02-13, under 510(k) number K864705.

Who is the listed applicant for MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH?

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 MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH?

The FDA product code for MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH is DYB.

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Other records listing Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

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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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