Cleared Traditional

K011208 - BIOVER

K011208 is an FDA 510(k) clearance for BIOVER, manufactured by Biover AG. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 531-day FDA review.

K011208 · Biover AG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
531d
Days
Class 2
Risk

K011208 is an FDA 510(k) clearance for the BIOVER. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Biover AG (Ridley Park, US). The FDA issued a Cleared decision on October 2, 2002 after a review of 531 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

FDA 510(k) Submission Details - K011208

510(k) Number K011208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date October 02, 2002
Days to Decision 531 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
406d slower than avg
Panel avg: 125d · This submission: 531d
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 202
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K011208.
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
K014277 · KARL STORZ Endoscopy-America, Inc. · Dec 2002
SMITHWICK CAROTID SHUNT
K021608 · Implantable Devices · Oct 2002
S&T SINGLE USE MICRO ANASTOMOSIS CLAMP
K022754 · S & T AG · Oct 2002
GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
K022880 · Guidant Corp. · Sep 2002
FLEXLINE CLAMP
K010727 · Novare Surgical Systems, Inc. · Aug 2002
THE HAMMER MODEL H100
K012041 · Tenacore Holdings, Inc. · Mar 2002
K011208 · BIOVER
Download PDF FDA Summary Biover AG