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FDA 510(k)

CLEARGUARD HD END CAP

K-Number: K131060 · 2013-12-16

ApplicantPursuit Vascular, Inc.
Decision Date2013-12-16
Product CodePEH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CLEARGUARD HD END CAP is the device name listed in this FDA 510(k) record. The listed applicant is Pursuit Vascular, Inc.. It received FDA 510(k) clearance on 2013-12-16 under 510(k) number K131060. The device is classified under product code PEH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARGUARD HD END CAP?

CLEARGUARD HD END CAP is a medical device that received FDA 510(k) clearance on 2013-12-16. The listed applicant is Pursuit Vascular, Inc.. The 510(k) number is K131060.

When did CLEARGUARD HD END CAP receive FDA 510(k) clearance?

CLEARGUARD HD END CAP received FDA 510(k) clearance on 2013-12-16, under 510(k) number K131060.

Who is the listed applicant for CLEARGUARD HD END CAP?

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

What is the FDA product code for CLEARGUARD HD END CAP?

The FDA product code for CLEARGUARD HD END CAP is PEH.

Related Clinical Trials

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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Other records listing Pursuit Vascular, 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.

K180111ClearGuard HD Antimicrobial Barrier Cap

Related Devices (Code: PEH)

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.

K180111ClearGuard HD Antimicrobial Barrier CapPursuit Vascular, Inc.

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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