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FDA 510(k)

TOPSEAL HEMOSTATIC DRESSING, MODEL 11150

K-Number: K033291 · 2004-03-17

ApplicantRadi Medical Systems AB
Decision Date2004-03-17
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 is the device name listed in this FDA 510(k) record. The listed applicant is Radi Medical Systems AB. It received FDA 510(k) clearance on 2004-03-17 under 510(k) number K033291. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPSEAL HEMOSTATIC DRESSING, MODEL 11150?

TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 is a medical device that received FDA 510(k) clearance on 2004-03-17. The listed applicant is Radi Medical Systems AB. The 510(k) number is K033291.

When did TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 receive FDA 510(k) clearance?

TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 received FDA 510(k) clearance on 2004-03-17, under 510(k) number K033291.

Who is the listed applicant for TOPSEAL HEMOSTATIC DRESSING, MODEL 11150?

The FDA 510(k) record lists Radi Medical Systems AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOPSEAL HEMOSTATIC DRESSING, MODEL 11150?

The FDA product code for TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 is QSY.

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Other records listing Radi Medical Systems AB 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.

K123984QUANTIEN MEASUREMENT SYSTEMK092105RADIANALYZER XPRESSK080813PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVERK080206MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEMK062769PRESSUREWIRE CERTUS, MODELS 12006 AND 12306K042628MODIFICATION TO: RADIANALYZER, MODEL 12711

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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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