Cleared Traditional

K030627 - ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110

K030627 is an FDA 510(k) clearance for ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K030627 · C.R. Bard, Inc. · Cardiovascular device
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Oct 2003
Decision
238d
Days
Class 2
Risk

K030627 is an FDA 510(k) clearance for the ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Lowell, US). The FDA issued a Cleared decision on October 23, 2003 after a review of 238 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K030627

510(k) Number K030627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2003
Decision Date October 23, 2003
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 140
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K030627.
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