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FDA 510(k)

PEEL-AWAY INTRODUCER SET

K-Number: K844693 · 1985-03-06

ApplicantQuinton, Inc.
Decision Date1985-03-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PEEL-AWAY INTRODUCER SET is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1985-03-06 under 510(k) number K844693. 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 PEEL-AWAY INTRODUCER SET?

PEEL-AWAY INTRODUCER SET is a medical device that received FDA 510(k) clearance on 1985-03-06. The listed applicant is Quinton, Inc.. The 510(k) number is K844693.

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

PEEL-AWAY INTRODUCER SET received FDA 510(k) clearance on 1985-03-06, under 510(k) number K844693.

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

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 PEEL-AWAY INTRODUCER SET?

The FDA product code for PEEL-AWAY INTRODUCER SET 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.

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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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