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FDA 510(k)

AMSINO SUCTION CATHETER

K-Number: K973199 · 1997-09-10

ApplicantAmsino Intl., Inc.
Decision Date1997-09-10
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AMSINO SUCTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Amsino Intl., Inc.. It received FDA 510(k) clearance on 1997-09-10 under 510(k) number K973199. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSINO SUCTION CATHETER?

AMSINO SUCTION CATHETER is a medical device that received FDA 510(k) clearance on 1997-09-10. The listed applicant is Amsino Intl., Inc.. The 510(k) number is K973199.

When did AMSINO SUCTION CATHETER receive FDA 510(k) clearance?

AMSINO SUCTION CATHETER received FDA 510(k) clearance on 1997-09-10, under 510(k) number K973199.

Who is the listed applicant for AMSINO SUCTION CATHETER?

The FDA 510(k) record lists Amsino Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMSINO SUCTION CATHETER?

The FDA product code for AMSINO SUCTION CATHETER is BSY.

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Other records listing Amsino Intl., 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.

K070873AMSURE BLADDER IRRIGATION SETK992719AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKEK974042AMSURE CLEANSING ENEMA SETK973107AMSINO I.V. ADMINISTRATION SETK971929AMSINO URINARY LEG BAGK964745AMSINO URINARY DRAINAGE BAG

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK961707TRACH-EZE CLOSED VENTILATION SUCTION SYSTEMSorenson Critical Care

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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