Cleared Traditional

K980002 - KOALA VASCULAR CLAMPS AND INSERTS

K980002 is an FDA 510(k) clearance for KOALA VASCULAR CLAMPS AND INSERTS, manufactured by Boss Instruments, Ltd.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K980002 · Boss Instruments, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
167d
Days
Class 2
Risk

K980002 is an FDA 510(k) clearance for the KOALA VASCULAR CLAMPS AND INSERTS. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Boss Instruments, Ltd. (Hermitage, US). The FDA issued a Cleared decision on June 18, 1998 after a review of 167 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 Boss Instruments, Ltd. devices

FDA 510(k) Submission Details - K980002

510(k) Number K980002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1998
Decision Date June 18, 1998
Days to Decision 167 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
42d slower than avg
Panel avg: 125d · This submission: 167d
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 K980002.
BALADI INVERTER WITH COAXIAL AORTIC PUNCH
K980128 · Cardio Medical Solutions, Inc. · Jul 1998
DEGANIA SILICONE IDENTI LOOPS
K981956 · Degania Silicone , Ltd. · Jul 1998
PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330
K980087 · Pressure Products, Inc. · Jul 1998
COSGROVE CLAMP
K974769 · Allegiance Healthcare Corp. · Jun 1998
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER
K980898 · Radi Medical Systems AB · Apr 1998
SURGICAL VASCULAR CLAMP
K973080 · Walter Lorenz Surgical, Inc. · Feb 1998