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FDA 510(k)

PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,

K-Number: K844876 · 1985-06-05

ApplicantPennine Medical , Ltd.
Decision Date1985-06-05
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, is the device name listed in this FDA 510(k) record. The listed applicant is Pennine Medical , Ltd.. It received FDA 510(k) clearance on 1985-06-05 under 510(k) number K844876. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,?

PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, is a medical device that received FDA 510(k) clearance on 1985-06-05. The listed applicant is Pennine Medical , Ltd.. The 510(k) number is K844876.

When did PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, receive FDA 510(k) clearance?

PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, received FDA 510(k) clearance on 1985-06-05, under 510(k) number K844876.

Who is the listed applicant for PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,?

The FDA 510(k) record lists Pennine Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16,?

The FDA product code for PENNINE NELATON CATHETERS SIZES 5,6,8,10,12,14,16, is GBX.

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Other records listing Pennine Medical , Ltd. 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.

K854443O'NEIL URINARY CATHETER INTRODUCERK852859PENNINE CONNECTING TUBINGK852081PENNINE OXYGEN LINK TUBINGK844874PENNINE LINK YANKAUERSK852080PENNINE SUCTION CATHETERSK852079PENNINE DERBY YANKAUER

View all 8 devices →

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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