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FDA 510(k)

TRACHEOSTOMY CLEANING TRAY

K-Number: K840664 · 1984-03-12

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1984-03-12
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACHEOSTOMY CLEANING TRAY 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 1984-03-12 under 510(k) number K840664. 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 TRACHEOSTOMY CLEANING TRAY?

TRACHEOSTOMY CLEANING TRAY is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K840664.

When did TRACHEOSTOMY CLEANING TRAY receive FDA 510(k) clearance?

TRACHEOSTOMY CLEANING TRAY received FDA 510(k) clearance on 1984-03-12, under 510(k) number K840664.

Who is the listed applicant for TRACHEOSTOMY CLEANING TRAY?

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 TRACHEOSTOMY CLEANING TRAY?

The FDA product code for TRACHEOSTOMY CLEANING TRAY 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 DEVICEK874517PHARMASEAL RUBBER URETHRAL CATHETERK874045PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWERK873359AIRLIFE 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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