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FDA 510(k)

PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY

K-Number: K813335 · 1982-01-08

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1982-01-08
Product CodeFSH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS TRANSHEPATIC CHOLANG. 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 1982-01-08 under 510(k) number K813335. The device is classified under product code FSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY?

PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY is a medical device that received FDA 510(k) clearance on 1982-01-08. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K813335.

When did PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY receive FDA 510(k) clearance?

PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY received FDA 510(k) clearance on 1982-01-08, under 510(k) number K813335.

Who is the listed applicant for PERCUTANEOUS TRANSHEPATIC CHOLANG. 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 PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY?

The FDA product code for PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY is FSH.

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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: FSH)

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.

K884876S 4 INSTRUMENT STANDCarl Zeiss, Inc.K883578S 21 INSTRUMENT STANDCarl Zeiss, Inc.K821921STAND, SURG. INSTRUMENT & DRESSINGEmerson-Sack-Warner Corp.K813337SKINNY CHIBA NEEDLE & TRAYAmerican Pharmaseal Div. AhscK813338BIOPSY NEEDLES & TRAYSAmerican Pharmaseal Div. AhscK780759MODEL 902 STANDApplied Medical Research

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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