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FDA 510(k)

OPTICAL CATHETER INTRODUCER SETS, MODIFICATION

K-Number: K914315 · 1992-03-04

ApplicantMedical Dynamics, Inc.
Decision Date1992-03-04
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPTICAL CATHETER INTRODUCER SETS, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Medical Dynamics, Inc.. It received FDA 510(k) clearance on 1992-03-04 under 510(k) number K914315. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICAL CATHETER INTRODUCER SETS, MODIFICATION?

OPTICAL CATHETER INTRODUCER SETS, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-03-04. The listed applicant is Medical Dynamics, Inc.. The 510(k) number is K914315.

When did OPTICAL CATHETER INTRODUCER SETS, MODIFICATION receive FDA 510(k) clearance?

OPTICAL CATHETER INTRODUCER SETS, MODIFICATION received FDA 510(k) clearance on 1992-03-04, under 510(k) number K914315.

Who is the listed applicant for OPTICAL CATHETER INTRODUCER SETS, MODIFICATION?

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

What is the FDA product code for OPTICAL CATHETER INTRODUCER SETS, MODIFICATION?

The FDA product code for OPTICAL CATHETER INTRODUCER SETS, MODIFICATION is KGX.

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Other records listing Medical Dynamics, Inc. 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.

K974542TRUE VISION, TRUE VISION IIK921294VIDEO ENDOSCOPE-RIGID MODIFICATIONK934682SURGICAL VIDEO CAMERA AND ACCESSORIESK930568ADAIR/VERESS NEEDLE INTRODUCER SETK915538OVER THE WIRE STONE BASKETK913986CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM

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Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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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