Cleared Traditional

BALADI INVERTER WITH COAXIAL AORTIC PUNCH (K980128) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980128 · Cardio Medical Solutions, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1998
Decision
191d
Days
Class 2
Risk

K980128 is an FDA 510(k) clearance for the BALADI INVERTER WITH COAXIAL AORTIC PUNCH. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Cardio Medical Solutions, Inc. (Fountain Valley, US). The FDA issued a Cleared decision on July 24, 1998 after a review of 191 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Cardio Medical Solutions, Inc. devices

Submission Details

510(k) Number K980128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1998
Decision Date July 24, 1998
Days to Decision 191 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 125d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 34
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K980128.
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · KARL STORZ Endoscopy-America, Inc. · Dec 2002
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc. · Aug 2001
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
OCCLUSION CLAMP** DEVICE
K964251 · United States Surgical, A Division of Tyco Healthc · May 1997
FOGARTY-HYDRAGRIP SURGICAL CLAMPS
K951413 · Baxter Healthcare Corp · Aug 1995
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc · Feb 1988