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FDA 510(k)

CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET

K-Number: K870704 · 1987-03-27

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1987-03-27
Product CodeGBX
Advisory CommitteeSU
DecisionUnknown

Device Summary

CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET 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 1987-03-27 under 510(k) number K870704. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET?

CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET is a medical device that received FDA 510(k) clearance on 1987-03-27. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K870704.

When did CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET receive FDA 510(k) clearance?

CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET received FDA 510(k) clearance on 1987-03-27, under 510(k) number K870704.

Who is the listed applicant for CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET?

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 CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET?

The FDA product code for CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET is GBX.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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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: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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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