Cleared Traditional

K983506 - PRESSUREWIRE SENSOR

K983506 is an FDA 510(k) clearance for PRESSUREWIRE SENSOR, manufactured by Radi Medical Systems AB. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K983506 · Radi Medical Systems AB · Cardiovascular device
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Feb 1999
Decision
119d
Days
Class 2
Risk

K983506 is an FDA 510(k) clearance for the PRESSUREWIRE SENSOR, MODEL #12001. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on February 3, 1999 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Radi Medical Systems AB devices

FDA 510(k) Submission Details - K983506

510(k) Number K983506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1998
Decision Date February 03, 1999
Days to Decision 119 days
Submission Type Traditional
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
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 540
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K983506.
ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.
K990639 · Guidant Corp. · Mar 1999
STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF
K983346 · Guidant Corp. · Mar 1999
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
K984394 · Guidant Corp. · Mar 1999
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018
K982272 · Biotronik, Inc. · Jan 1999
SILVERSTREAK HYDROPHILIC GUIDEWIRE
K982543 · Micro Therapeutics, Inc. · Dec 1998
SCIMED INFORMER PRESSURE WIRE SYSTEM
K974241 · Scimed Life Systems, Inc. · Nov 1998