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FDA 510(k)

SUCTION CATHETERS & KITS

K-Number: K820369 · 1982-04-16

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1982-04-16
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUCTION CATHETERS & KITS is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1982-04-16 under 510(k) number K820369. 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 SUCTION CATHETERS & KITS?

SUCTION CATHETERS & KITS is a medical device that received FDA 510(k) clearance on 1982-04-16. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K820369.

When did SUCTION CATHETERS & KITS receive FDA 510(k) clearance?

SUCTION CATHETERS & KITS received FDA 510(k) clearance on 1982-04-16, under 510(k) number K820369.

Who is the listed applicant for SUCTION CATHETERS & KITS?

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

What is the FDA product code for SUCTION CATHETERS & KITS?

The FDA product code for SUCTION CATHETERS & KITS is BSY.

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Other records listing American Pharmaseal Div. Ahsc 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.

K874022PHARMASEAL WOUND IRRIGATION DEVICEK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK874517PHARMASEAL RUBBER URETHRAL CATHETERK873359AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVEK872228PHARMASEAL ALTERNATING PRESSURE PAD SYSTEMK872917JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER

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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 MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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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