Cleared Special

K060715 - MODIFICATION TO: CARDIMA ABLATION SYSTEM

K060715 is an FDA 510(k) clearance for MODIFICATION TO: CARDIMA ABLATION SYSTEM, manufactured by Cardima, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Special 510(k) pathway after a 59-day FDA review.

K060715 · Cardima, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
59d
Days
Class 2
Risk

K060715 is an FDA 510(k) clearance for the MODIFICATION TO: CARDIMA ABLATION SYSTEM. Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by Cardima, Inc. (Fremont, US). The FDA issued a Cleared decision on May 15, 2006 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - 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 - K060715

510(k) Number K060715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2006
Decision Date May 15, 2006
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

OCL Device Classification - Class 2, Special Controls

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
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 - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 53
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K060715.
NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
K063012 · Ncontact Surgical, Inc. · Dec 2006
SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL
K062140 · Cryocath Technologies, Inc. · Aug 2006
ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
K061593 · AtriCure, Inc. · Jul 2006
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
K053436 · Cryocath Technologies, Inc. · Jan 2006
ATRICURE ISOLATOR TRANSPOLAR PEN
K050459 · AtriCure, Inc. · Jun 2005
CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
K041890 · Cryocor, Inc. · Sep 2004
K060715 · MODIFICATION TO: CARDIMA ABLATION SYSTEM
Download PDF FDA Summary Cardima, Inc.