FDA 510(k)

KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS

K-Number: K030788 · 2003-07-12

Decision Date2003-07-12

Product CodeDWP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Geister Medizin Technik GmbH. It received FDA 510(k) clearance on 2003-07-12 under 510(k) number K030788. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS?

KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS is a medical device that received FDA 510(k) clearance on 2003-07-12. The listed applicant is Geister Medizin Technik GmbH. The 510(k) number is K030788.

When did KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS receive FDA 510(k) clearance?

KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS received FDA 510(k) clearance on 2003-07-12, under 510(k) number K030788.

Who is the listed applicant for KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS?

The FDA 510(k) record lists Geister Medizin Technik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS?

The FDA product code for KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS is DWP.

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 Geister Medizin Technik GmbH as applicant

K242759Geister K-Rex rongeurs K180610Geister retractor for neuro - and spine surgery K022823VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 K982365ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT K933699GEISTER SURGICAL INT'L BIPOLAR ENDOSCOPIC SURGICAL INSTRUMENTS

Related Devices (Code: DWP)

K220981SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc.K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co.K163524Vessel DilatorFetzer Medical GmbH & Co. KG K130896VASCULAR PROBE, VASCULAR PROBE ESSynovis Life Technologies, Inc.K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.K960312RDI CARDIAC INSULATION PADR D Intl.

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.