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FDA 510(k)

CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER

K-Number: K132197 · 2013-08-12

ApplicantPendracare International, B.V.
Decision Date2013-08-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Pendracare International, B.V.. It received FDA 510(k) clearance on 2013-08-12 under 510(k) number K132197. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER?

CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 2013-08-12. The listed applicant is Pendracare International, B.V.. The 510(k) number is K132197.

When did CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER receive FDA 510(k) clearance?

CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER received FDA 510(k) clearance on 2013-08-12, under 510(k) number K132197.

Who is the listed applicant for CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER?

The FDA 510(k) record lists Pendracare International, B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER?

The FDA product code for CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER is DQY.

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 Pendracare International, B.V. 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.

K120585CONVEY GUIDING CATHETER

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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