Cleared Traditional

K070605 - JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING (FDA 510(k) Clearance)

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

K070605 · Maquet Cardiopulmonary, AG · Cardiovascular device
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Jan 2008
Decision
305d
Days
Class 2
Risk

K070605 is an FDA 510(k) clearance for the JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Hirrlingen, DE). The FDA issued a Cleared decision on January 4, 2008 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Maquet Cardiopulmonary, AG devices

Submission Details

510(k) Number K070605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2007
Decision Date January 04, 2008
Days to Decision 305 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
180d slower than avg
Panel avg: 125d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 168
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