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FDA 510(k)

GUARDPORT

K-Number: K921478 · 1995-01-11

ApplicantHealth Improvement Assoc.
Decision Date1995-01-11
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GUARDPORT is the device name listed in this FDA 510(k) record. The listed applicant is Health Improvement Assoc.. It received FDA 510(k) clearance on 1995-01-11 under 510(k) number K921478. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUARDPORT?

GUARDPORT is a medical device that received FDA 510(k) clearance on 1995-01-11. The listed applicant is Health Improvement Assoc.. The 510(k) number is K921478.

When did GUARDPORT receive FDA 510(k) clearance?

GUARDPORT received FDA 510(k) clearance on 1995-01-11, under 510(k) number K921478.

Who is the listed applicant for GUARDPORT?

The FDA 510(k) record lists Health Improvement Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GUARDPORT?

The FDA product code for GUARDPORT is KNT.

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Other records listing Health Improvement Assoc. 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.

K905677JEJUNO-CATH KITK875232INTRO-REDUCER (NASOGASTRIC TUBE)K770086SANAR

Related Devices (Code: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

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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