Cleared Special

K990958 - ORTHOGONAL EP CATHETERS

K990958 is an FDA 510(k) clearance for ORTHOGONAL EP CATHETERS, manufactured by Irvine Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Special 510(k) pathway after a 73-day FDA review.

K990958 · Irvine Biomedical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
73d
Days
Class 2
Risk

K990958 is an FDA 510(k) clearance for the ORTHOGONAL EP CATHETERS. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Irvine Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on June 3, 1999 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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.

FDA 510(k) Submission Details - K990958

510(k) Number K990958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1999
Decision Date June 03, 1999
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
Pathway characteristics
Modification to existing cleared device.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 180
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K990958.
LUMA-CATH FIXED CURVE EP CATHETERS
K991025 · Irvine Biomedical, Inc. · Oct 1999
CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
K991531 · Cordis Webster, Inc. · Oct 1999
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
K991001 · Ep Medsystems · Jul 1999
TRACER O-T-W MAPPING DEVICE
K972803 · Cardima, Inc. · May 1999
PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
K984150 · Ep Medsystems · Feb 1999
RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D
K983653 · Cardiac Pathways Corp. · Dec 1998
K990958 · ORTHOGONAL EP CATHETERS
Download PDF FDA Summary Irvine Biomedical, In…