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FDA 510(k)

EPICATH

K-Number: K862358 · 1986-07-07

ApplicantHdc Corp.
Decision Date1986-07-07
Product CodeKNE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EPICATH is the device name listed in this FDA 510(k) record. The listed applicant is Hdc Corp.. It received FDA 510(k) clearance on 1986-07-07 under 510(k) number K862358. The device is classified under product code KNE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPICATH?

EPICATH is a medical device that received FDA 510(k) clearance on 1986-07-07. The listed applicant is Hdc Corp.. The 510(k) number is K862358.

When did EPICATH receive FDA 510(k) clearance?

EPICATH received FDA 510(k) clearance on 1986-07-07, under 510(k) number K862358.

Who is the listed applicant for EPICATH?

The FDA 510(k) record lists Hdc Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPICATH?

The FDA product code for EPICATH is KNE.

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Other records listing Hdc Corp. 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.

K071875V-CATH POLY PICCK023342NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BGK033853MODIFICATION TO V-CATH POLY PICCK032404SELDINGER SAFETY NEEDLE INTRODUCERK022752PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15K022099SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S

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Related Devices (Code: KNE)

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.

K880988PUDENDAL/LOCAL ANESTESIA BLOCK TRAYBd Becton Dickinson Vacutainer Systems Preanalytic

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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