Cleared Traditional

K070605 - JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING

K070605 is an FDA 510(k) clearance for JOSTRA VENOUS SOFTBAG RESERVOIRS WITH A..., manufactured by Maquet Cardiopulmonary, AG. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 305-day FDA review.

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

FDA 510(k) Submission Details - K070605

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
Combination Product No
PCCP Authorized No
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.

DTN Device Classification - Class 2, Special Controls

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 147
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K070605.
MEDOS HILITE RESERVOIR, MODEL: 4030
K083131 · Gish Biomedical, Inc. · Jul 2009
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
K081947 · Gish Biomedical, Inc. · Feb 2009
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
K082082 · Gish Biomedical, Inc. · Feb 2009
MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR
K070839 · Terumo Cardiovascular Systems Corp. · Apr 2007
VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000
K061743 · Maquet Cardiopulmonary, AG · Jul 2006
CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
K061527 · Sorin Group Italia S.R.L. · Jun 2006