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FDA 510(k)

HOSPAL TIPSTOP

K-Number: K982818 · 1998-10-21

ApplicantGambro Healthcare
Decision Date1998-10-21
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HOSPAL TIPSTOP is the device name listed in this FDA 510(k) record. The listed applicant is Gambro Healthcare. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K982818. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOSPAL TIPSTOP?

HOSPAL TIPSTOP is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Gambro Healthcare. The 510(k) number is K982818.

When did HOSPAL TIPSTOP receive FDA 510(k) clearance?

HOSPAL TIPSTOP received FDA 510(k) clearance on 1998-10-21, under 510(k) number K982818.

Who is the listed applicant for HOSPAL TIPSTOP?

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

What is the FDA product code for HOSPAL TIPSTOP?

The FDA product code for HOSPAL TIPSTOP is KMF.

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Other records listing Gambro Healthcare 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.

K994390GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTERK990039GAMBRO DQM 200K982413COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERSK982414GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERSK980386HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)K982760COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET

View all 13 devices →

Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, Inc.

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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