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FDA 510(k)

KAPLAN-SIMPSON INFUSASLEEVE CATHETER

K-Number: K950615 · 1995-04-19

ApplicantLocalmed, Inc.
Decision Date1995-04-19
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KAPLAN-SIMPSON INFUSASLEEVE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Localmed, Inc.. It received FDA 510(k) clearance on 1995-04-19 under 510(k) number K950615. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAPLAN-SIMPSON INFUSASLEEVE CATHETER?

KAPLAN-SIMPSON INFUSASLEEVE CATHETER is a medical device that received FDA 510(k) clearance on 1995-04-19. The listed applicant is Localmed, Inc.. The 510(k) number is K950615.

When did KAPLAN-SIMPSON INFUSASLEEVE CATHETER receive FDA 510(k) clearance?

KAPLAN-SIMPSON INFUSASLEEVE CATHETER received FDA 510(k) clearance on 1995-04-19, under 510(k) number K950615.

Who is the listed applicant for KAPLAN-SIMPSON INFUSASLEEVE CATHETER?

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

What is the FDA product code for KAPLAN-SIMPSON INFUSASLEEVE CATHETER?

The FDA product code for KAPLAN-SIMPSON INFUSASLEEVE CATHETER is QEY.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Localmed, 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.

K980957KAPLAN-SIMPSON INFUSASLEEVE IIK972175INFUSASLEEVE IIA (IS-2A)K952317Kaplan-Simpson InfusaSleeve II CatheterK935349LOCALMED INFUSION CATHETER

Related Devices (Code: QEY)

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.

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston Scientific

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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