Cleared Traditional

K980128 - BALADI INVERTER WITH COAXIAL AORTIC PUNCH

K980128 is an FDA 510(k) clearance for BALADI INVERTER WITH COAXIAL AORTIC PUNCH, manufactured by Cardio Medical Solutions, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K980128 · Cardio Medical Solutions, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K980128

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
Combination Product No
PCCP Authorized No
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.

DXC Device Classification - Class 2, Special Controls

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 150
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K980128.
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0
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FLO-THRU
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K980087 · Pressure Products, Inc. · Jul 1998
KOALA VASCULAR CLAMPS AND INSERTS
K980002 · Boss Instruments, Ltd. · Jun 1998