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FDA 510(k)

KALTOSTAT WOUND DRESSING

K-Number: K904488 · 1990-12-12

ApplicantCalgon Vestal Div.
Decision Date1990-12-12
Product CodeQSY
DecisionSubstantially Equivalent for Some Indications

Device Summary

KALTOSTAT WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Calgon Vestal Div.. It received FDA 510(k) clearance on 1990-12-12 under 510(k) number K904488. The device is classified under product code QSY. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the KALTOSTAT WOUND DRESSING?

KALTOSTAT WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1990-12-12. The listed applicant is Calgon Vestal Div.. The 510(k) number is K904488.

When did KALTOSTAT WOUND DRESSING receive FDA 510(k) clearance?

KALTOSTAT WOUND DRESSING received FDA 510(k) clearance on 1990-12-12, under 510(k) number K904488.

Who is the listed applicant for KALTOSTAT WOUND DRESSING?

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

What is the FDA product code for KALTOSTAT WOUND DRESSING?

The FDA product code for KALTOSTAT WOUND DRESSING is QSY.

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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 Calgon Vestal Div. 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.

K944494ALSA-KLENZK944033BILL EVANS-KLENZK942270SAF-GEL HYDRATING DERMAL WOUND DRESSINGK931477AMERSEK931342LPHK931816VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM

View all 19 devices →

Related Devices (Code: QSY)

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.

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cmSpeciality Fibres and Materials LimitedK250319MFUSE (MS001)Machina Medical, Inc.K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, 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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