# K051606: Gish ATR2900 and CAP35 Series Reservoirs with GBS Coating

- Pathway: 510(k) (Traditional)
- Applicant: Gish Biomedical, Inc.
- Decided: Aug 12, 2005 after 57 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gish ATR2900DF Reservoir: named in the summary without a submission number
- (no number) Gish 35DF Reservoir: named in the summary without a submission number

## Indications for use
The Gish ATR2900 Series Reservoirs with GBS TM Coating are indicated for use: 1. During cardiopulmonary bypass surgery to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. 2. During general surgery procedures other than cardiopulmonary bypass, for collection and filtration of suctioned blood. During these procedures, the reservoir must be used in conjunction with appropriate cell-washing techniques. 3. Once intraoperative use is completed, for the collection and autotransfusion of the same patients post operative blood using components available separately in the SVP400 or SVP450 STAT-VAC Conversion Pack, ATR200 or ATR250 Supplemental Drainage Set, ATR500 Wound drainage Postoperative Pack or ATR600 Supplemental Wound Drainage Line Set. 4. With or without a water seal when used for postoperative autotransfusion, depending on user preference and application. The SVP400, SVP450 and STAT-VAC provide a water seal for use with ATR2900. The attending physician is solely responsible for the decision to use or not to use a water seal.. The Gish CAP35 Series Reservoirs with GBS TM Coating with integral water seal/water manometer are indicated for use during cardiopulmonary bypass surgery to filter/defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The CAP35 Series Reservoirs are indicated for the collection and autotransfusion of the same patients postoperative shed blood, using components available separately in the CAP400 or CAP450 Postoperative Conversion Pack and ATR200 or ATR250 Supplemental Drainage Set. The Gish CAP400/450 Pack is indicated for use exclusively with the Gish CAP Series Products: The Gish CAP400/450 Pack provides components used to convert the Gish CAP systems from intraoperative to post operative use.

Source page: https://510kreport.com/device/K051606
Methodology: https://510kreport.com/methodology