Cleared Special

K001736 - GALEO HYDRO AND GALEO HYDRO J-TIP

K001736 is an FDA 510(k) clearance for GALEO HYDRO AND GALEO HYDRO J-TIP, manufactured by Biotronik, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 56-day FDA review.

K001736 · Biotronik, Inc. · Cardiovascular device
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Aug 2000
Decision
56d
Days
Class 2
Risk

K001736 is an FDA 510(k) clearance for the GALEO HYDRO AND GALEO HYDRO J-TIP. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on August 2, 2000 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Biotronik, Inc. devices

FDA 510(k) Submission Details - K001736

510(k) Number K001736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2000
Decision Date August 02, 2000
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K001736.
PRESSURE WIRE SENSOR, MODEL 12003/12303
K002962 · Radi Medical Systems AB · Oct 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
K002206 · Guidant Corp. · Aug 2000
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
K002212 · Micro Therapeutics, Inc. · Aug 2000
SNIPER, MODEL OR-3872XX SERIES
K001251 · Nipro Medical Corp. · Jul 2000
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
K001454 · Micro Therapeutics, Inc. · Jun 2000
DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET
K001198 · Datascope Corp. · May 2000