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FDA 510(k)

MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT

K-Number: K945413 · 1995-05-24

ApplicantMedtronic Vascular
Decision Date1995-05-24
Product CodeMAJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1995-05-24 under 510(k) number K945413. The device is classified under product code MAJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT?

MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT is a medical device that received FDA 510(k) clearance on 1995-05-24. The listed applicant is Medtronic Vascular. The 510(k) number is K945413.

When did MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT receive FDA 510(k) clearance?

MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT received FDA 510(k) clearance on 1995-05-24, under 510(k) number K945413.

Who is the listed applicant for MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT?

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

What is the FDA product code for MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT?

The FDA product code for MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT is MAJ.

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Related Devices (Code: MAJ)

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.

K965251MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEMMedtronic VascularK934939TEMPORARY SCREENING LEAD/ CATHETER KITMedtronic VascularK930218SUBCUTANEOUS TUNNELING NEEDLE AND HANDLESConcord/PortexK911382IPI ALGO-LINE CATHETERPudenz-Schulte Medical Research Corp.K893766LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATEAbbott Laboratories

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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