FDA 510(k)

ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200

K-Number: K023629 · 2002-11-12

ApplicantGuidant Corporation, Cardiac Surgery

Decision Date2002-11-12

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corporation, Cardiac Surgery. It received FDA 510(k) clearance on 2002-11-12 under 510(k) number K023629. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200?

ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 is a medical device that received FDA 510(k) clearance on 2002-11-12. The listed applicant is Guidant Corporation, Cardiac Surgery. The 510(k) number is K023629.

When did ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 receive FDA 510(k) clearance?

ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 received FDA 510(k) clearance on 2002-11-12, under 510(k) number K023629.

Who is the listed applicant for ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200?

The FDA 510(k) record lists Guidant Corporation, Cardiac Surgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200?

The FDA product code for ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 is GCJ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Guidant Corporation, Cardiac Surgery as applicant

K080169HEARTSTRING III PROXIMAL SEAL SYSTEM K041340GUIDANT MICROWAVE ABLATION SYSTEM K023630ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400 K024071GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM K022718VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002 K020701SYNCRUS INTERNAL CARDIOVERSION SYSTEM

View all 8 devices →

Related Devices (Code: GCJ)

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical Impact K261614LED LCD Monitor (OEV-271H)Lg Electronics.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.