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FDA 510(k)

INFUSASLEEVE IIA (IS-2A)

K-Number: K972175 · 1997-08-28

ApplicantLocalmed, Inc.
Decision Date1997-08-28
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFUSASLEEVE IIA (IS-2A) is the device name listed in this FDA 510(k) record. The listed applicant is Localmed, Inc.. It received FDA 510(k) clearance on 1997-08-28 under 510(k) number K972175. 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 INFUSASLEEVE IIA (IS-2A)?

INFUSASLEEVE IIA (IS-2A) is a medical device that received FDA 510(k) clearance on 1997-08-28. The listed applicant is Localmed, Inc.. The 510(k) number is K972175.

When did INFUSASLEEVE IIA (IS-2A) receive FDA 510(k) clearance?

INFUSASLEEVE IIA (IS-2A) received FDA 510(k) clearance on 1997-08-28, under 510(k) number K972175.

Who is the listed applicant for INFUSASLEEVE IIA (IS-2A)?

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 INFUSASLEEVE IIA (IS-2A)?

The FDA product code for INFUSASLEEVE IIA (IS-2A) 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.

K980957KAPLAN-SIMPSON INFUSASLEEVE IIK952317Kaplan-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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