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FDA 510(k)

KAPLAN-SIMPSON INFUSASLEEVE II

K-Number: K980957 · 1998-06-10

ApplicantLocalmed, Inc.
Decision Date1998-06-10
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KAPLAN-SIMPSON INFUSASLEEVE II is the device name listed in this FDA 510(k) record. The listed applicant is Localmed, Inc.. It received FDA 510(k) clearance on 1998-06-10 under 510(k) number K980957. 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 II?

KAPLAN-SIMPSON INFUSASLEEVE II is a medical device that received FDA 510(k) clearance on 1998-06-10. The listed applicant is Localmed, Inc.. The 510(k) number is K980957.

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

KAPLAN-SIMPSON INFUSASLEEVE II received FDA 510(k) clearance on 1998-06-10, under 510(k) number K980957.

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

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 II?

The FDA product code for KAPLAN-SIMPSON INFUSASLEEVE II 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.

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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.

K972175INFUSASLEEVE IIA (IS-2A)K952317Kaplan-Simpson InfusaSleeve II CatheterK950615KAPLAN-SIMPSON INFUSASLEEVE 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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