FDA 510(k)

CPS Direct Universal slittable outer guide catheter (DS2C029)

K-Number: K231311 · 2023-06-02

Decision Date2023-06-02

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CPS Direct Universal slittable outer guide catheter (DS2C029) is a medical device manufactured by ABBOTT MEDICAL. It received FDA 510(k) clearance on 2023-06-02 under approval 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. It is manufactured by ABBOTT MEDICAL. The 510(k) number is K231311.

When was CPS Direct Universal slittable outer guide catheter (DS2C029) approved by the FDA?

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

What company makes CPS Direct Universal slittable outer guide catheter (DS2C029)?

CPS Direct Universal slittable outer guide catheter (DS2C029) is manufactured by ABBOTT MEDICAL.

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.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING

Related PubMed Literature

PMID: 41929241 A Multidimensional Index Framework for Evaluating the Regulatory Applicability of ISO 10328 Using a Prosthetic Knee Case Study. Medical devices (Auckland, N.Z.) (2026)

Other Devices by ABBOTT MEDICAL

K192267ILUMIEN System with AptiVue Software version D.3 K192019Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 K192037Advisor VL Circular Mapping Catheter, Sensor Enabled K190581Amplatzer Trevisio Intravascular Delivery System K202066EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled K201610IonicRF Generator

View all 89 devices →

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, 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.