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FDA 510(k)

CERENOVUS Large Bore Catheter

K-Number: K191237 · 2019-11-08

ApplicantCodman & Shurtleff, Inc.
Decision Date2019-11-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CERENOVUS Large Bore Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191237. 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 CERENOVUS Large Bore Catheter?

CERENOVUS Large Bore Catheter is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K191237.

When did CERENOVUS Large Bore Catheter receive FDA 510(k) clearance?

CERENOVUS Large Bore Catheter received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191237.

Who is the listed applicant for CERENOVUS Large Bore Catheter?

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

What is the FDA product code for CERENOVUS Large Bore Catheter?

The FDA product code for CERENOVUS Large Bore 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.

NCT06851481The Ladera Suture-Mediated Large Bore Closure StudyCOMPLETEDNCT07541235The Ladera Suture-Mediated Large Bore Closure Pivotal StudyNOT_YET_RECRUITING

Other records listing Codman & Shurtleff, 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.

K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetK173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter KitK172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection BagK172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)K171862GALAXY G3 Mini Microcoil Delivery SystemK171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System

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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.

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 CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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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