Cleared Traditional

K974320 - CRYOGEN CARDIAC CRYOSURGICAL SYSTEM

K974320 is an FDA 510(k) clearance for CRYOGEN CARDIAC CRYOSURGICAL SYSTEM, manufactured by Cryogen, Inc.. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K974320 · Cryogen, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
78d
Days
Class 2
Risk

K974320 is an FDA 510(k) clearance for the CRYOGEN CARDIAC CRYOSURGICAL 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 Cryogen, Inc. (San Diego, US). The FDA issued a Cleared decision on February 3, 1998 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cryogen, Inc. devices

FDA 510(k) Submission Details - K974320

510(k) Number K974320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1997
Decision Date February 03, 1998
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 38
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K974320.
MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
K021010 · Endocare, Inc. · Jun 2002
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
K013392 · Medtronic Vascular · Jan 2002
CRYOCARE CARDIAC SURGICAL SYSTEM
K011040 · Endocare, Inc. · Jun 2001
HEARTPORT MAZE SYSTEM: CRYOPROBE SET
K970496 · Heartport, Inc. · May 1997