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FDA 510(k)

OPTICAL CATHETER(TM) INTRODUCER SETS

K-Number: K895041 · 1989-10-16

ApplicantMedical Dynamics, Inc.
Decision Date1989-10-16
Product CodeKGZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTICAL CATHETER(TM) INTRODUCER SETS 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 1989-10-16 under 510(k) number K895041. The device is classified under product code KGZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTICAL CATHETER(TM) INTRODUCER SETS?

OPTICAL CATHETER(TM) INTRODUCER SETS is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is Medical Dynamics, Inc.. The 510(k) number is K895041.

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

OPTICAL CATHETER(TM) INTRODUCER SETS received FDA 510(k) clearance on 1989-10-16, under 510(k) number K895041.

Who is the listed applicant for OPTICAL CATHETER(TM) INTRODUCER SETS?

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(TM) INTRODUCER SETS?

The FDA product code for OPTICAL CATHETER(TM) INTRODUCER SETS is KGZ.

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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 BASKETK914315OPTICAL CATHETER INTRODUCER SETS, MODIFICATION

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Related Devices (Code: KGZ)

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.

K022306AART SILICONE TUBINGAesthetic and Reconstructive Technologies, Inc.K974295BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBINGByron MedicalK973183WOUND DRAINAGE HOLDERR & D Medical Products, Inc.K955433DURALASTIC SILICONE TUBINGAllied Biomedical Corp.K942315NAVARRE PERCUTANEOUS ACCESS SETNavarre Biomedical , Ltd.K896087PALESTRANT IRRIGATION AND DRAINAGE SETNorth American Instrument Corp.

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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