Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CPS Direct™ Universal slittable outer guide catheter (DS2C029)

K-Number: K231311 · 2023-06-02

ApplicantABBOTT MEDICAL
Decision Date2023-06-02
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPS Direct™ Universal slittable outer guide catheter (DS2C029) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-06-02 under 510(k) number K231311. 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 CPS Direct™ Universal slittable outer guide catheter (DS2C029)?

CPS Direct™ Universal slittable outer guide catheter (DS2C029) is a medical device that received FDA 510(k) clearance on 2023-06-02. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K231311.

When did CPS Direct™ Universal slittable outer guide catheter (DS2C029) receive FDA 510(k) clearance?

CPS Direct™ Universal slittable outer guide catheter (DS2C029) received FDA 510(k) clearance on 2023-06-02, under 510(k) number K231311.

Who is the listed applicant for CPS Direct™ Universal slittable outer guide catheter (DS2C029)?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPS Direct™ Universal slittable outer guide catheter (DS2C029)?

The FDA product code for CPS Direct™ Universal slittable outer guide catheter (DS2C029) is DQY.

Other records listing ABBOTT MEDICAL 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.

PMA P910023Implantable cardioverter defibrillator (non-CRT)PMA P160054Ventricular (assist) bypassPMA P060040Ventricular (assist) bypassPMA P030054Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)PMA P250022Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible ElectroporationPMA P040021heart-valve, non-allograft tissue

View all 91 devices →

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.

↑