Cleared Special

K030779 - 5F MEDTRONIC LAUNCHER GUIDE CATHETER

K030779 is the FDA 510(k) clearance for 5F MEDTRONIC LAUNCHER GUIDE CATHETER by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 44-day FDA review.

K030779 · Medtronic Vascular · Cardiovascular device

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Apr 2003

Decision

44d

Days

Class 2

Risk

K030779 is an FDA 510(k) clearance for the 5F MEDTRONIC LAUNCHER GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on April 24, 2003 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Vascular devices

Submission Details

510(k) Number	K030779 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 11, 2003
Decision Date	April 24, 2003
Days to Decision	44 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

81d faster than avg

Panel avg: 125d · This submission: 44d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	DQY Catheter, Percutaneous
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.1250

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 589

Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K030779.

ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH

K031211 · Medtronic Vascular · Jul 2003

ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER

K031766 · Cook, Inc. · Jun 2003

MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS

K030589 · NuMED, Inc. · May 2003

MODIFIED CONCENTRIC RETRIEVER, MODEL 90037

K030476 · Concentric Medical, Inc. · Mar 2003

ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY

K024032 · Medtronic Vascular · Dec 2002

ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY

K024035 · Medtronic Vascular · Dec 2002

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K030779

Medtronic Vascular

Danvers, MA · US

FRED L BOUCHER

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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