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FDA 510(k)

OVAL PULL-APART SHEATH/DILATOR

K-Number: K873394 · 1987-09-30

ApplicantQuinton, Inc.
Decision Date1987-09-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OVAL PULL-APART SHEATH/DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1987-09-30 under 510(k) number K873394. 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 OVAL PULL-APART SHEATH/DILATOR?

OVAL PULL-APART SHEATH/DILATOR is a medical device that received FDA 510(k) clearance on 1987-09-30. The listed applicant is Quinton, Inc.. The 510(k) number is K873394.

When did OVAL PULL-APART SHEATH/DILATOR receive FDA 510(k) clearance?

OVAL PULL-APART SHEATH/DILATOR received FDA 510(k) clearance on 1987-09-30, under 510(k) number K873394.

Who is the listed applicant for OVAL PULL-APART SHEATH/DILATOR?

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 OVAL PULL-APART SHEATH/DILATOR?

The FDA product code for OVAL PULL-APART SHEATH/DILATOR is DYB.

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Other records listing Quinton, Inc. as applicant

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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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