Panels › Anesthesiology › Product code CAC · Class 2
Apparatus, Autotransfusion
Regulation 868.5830
0510(k)s in 12 months (195 all time)
0recalls in 12 months (114 all time)
99recalls that name a 510(k)
Top companies in CAC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2024 | Maquet Cardiovascular, LLC Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit Open, Classified |
CAC | K201305 |
| Jan 12, 2024 | Maquet Cardiovascular, LLC Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection Open, Classified |
CAC | K043140 |
| Dec 28, 2023 | Atrium Medical Corporation Atrium Oasis Drain Single W / AC, Part No. 3600-100 Open, Classified |
CAC | K043140 |
| Dec 2, 2023 | Atrium Medical Corporation Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY Open, Classified |
CAC | K043582 |
| Nov 16, 2023 | Atrium Medical Corporation Express Dry Seal Chest Drains (Express):
4000-100N DRAIN, EXPRESS, SINGLE;
4050-100N DRAIN, EXPRESS, BRU Open, Classified |
CAC | K043140 K201305 |
| Nov 16, 2023 | Atrium Medical Corporation Oasis Dry Suction Water Seal Chest Drains (Oasis):
(1)3600-100 DRAIN, OASIS SINGLE W/AC;
(2)3612-100 DRAIN, OASIS PEDI A/C;
(3)3650-100 DRAIN, OASIS BRU W/AC; Open, Classified |
CAC | K043140 K201305 |
| Nov 16, 2023 | Atrium Medical Corporation Ocean Water Seal Chest Drains (Ocean):
Products REF Number Product Name
(1)2002-000 DRAIN, OCEAN SINGLE W/AC,S;
(2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR;
(3)2002-100 DRAIN, OCEAN SINGLE W/AC; Open, Classified |
CAC | K201305 |
| Oct 21, 2019 | Haemonetics Corporation Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a res Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation Japan DISP SET, 263J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a res Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN CELL SAVER ELITE SET - 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processin Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN CELL SAVER ELITE SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processin Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN CS ELITE FASTPACK, 225ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing th Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation Japan CS Elite FASTPACK DISP. SET - 125ML - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, pr Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN DISP SET, 261J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a res Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN DISP SET, 261J, 205J, 208 - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a res Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN BASIC HI SPEED CS5 SET,LN 263J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation JAPAN LOW VOL(125ML) CS5 SET,LN 261J - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as Terminated |
CAC | None listed |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Fastpack, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent t Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Fastpack, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a resu Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Fastpack, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a resul Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Processing Set (125 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation CS Elite Processing Set (225 ml) Autotransfusion Device - Product Usage:its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result Terminated |
CAC | K101907 |
| Oct 21, 2019 | Haemonetics Corporation Cell Saver5/5+ Bowl Kit (225 ml) Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation CS5/5+ Fastpacks, 225 mL, 20 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation CS5/5+ Fastpacks, 125 mL, 20 Res Autotransfusion Device- Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to a Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation CS5/5+ Fastpacks, 125 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation High Speed Cell Saver5/5+ Bowl Set Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent t Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operati Terminated |
CAC | K932890 |
| Oct 21, 2019 | Haemonetics Corporation CS5/5+ Fastpacks, 225 mL, 150 Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to Terminated |
CAC | K932890 |
| Mar 5, 2019 | Fenwal Inc Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits:
1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 91 Terminated |
CAC | K160735 |
| Feb 11, 2019 | Fenwal Inc Vacuum Unit for CATSmart Vacuum Pump.
Fresenius CATSmart (Continuous Autotransfusion System) is indicated for the processing of blood collected intraoperatively and postoperatively to obtain washed p Terminated |
CAC | K180831 |
| Nov 27, 2018 | Medtronic Perfusion Systems SUCTION / ANTICOAGULATION ASSEMBLY
(a) BTC93
(b) BTC98
Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir. Open, Classified |
CAC | K812292 |
| Nov 27, 2018 | Medtronic Perfusion Systems RESERVOIR "Y" ADAPTER,
(a) BT920
(b) BT926
Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir. Open, Classified |
CAC | K803277 |
| Jul 13, 2018 | Haemonetics Corporation Haemonetics OrthoPAT System-OPAT QuickConnect Reservoirs.
Product Code: OPT-R-1000
The OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intra Terminated |
CAC | K122262 |
| Jul 13, 2018 | Haemonetics Corporation Haemonetics OrthoPAT System-Integrated Set.
Product Code: 1150H-00
OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and pos Terminated |
CAC | K992723 |
| Aug 2, 2017 | Haemonetics Corporation Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70
Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery Terminated |
CAC | K101907 |
| Aug 2, 2017 | Haemonetics Corporation Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00
Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recover Terminated |
CAC | K014083 |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC
Reference: 3612-100
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion a Terminated |
CAC | K043140 |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC
Reference: 4000-100N
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung ex Terminated |
CAC | K043140 K984496 |
| Dec 23, 2016 | Atrium Medical Corporation Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC
Reference: 3600-100
Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung Terminated |
CAC | K043140 |
| Mar 30, 2016 | Teleflex Medical Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical.
Product Usage:
Pleur-Evacs are sterile, single-use, chest drainage systems intended for pos Terminated |
CAC | K140205 |
| May 1, 2015 | Stryker Instruments Div. of Stryker Corporation Ambulating Bulb
Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female co Terminated |
CAC | K970714 |
| May 1, 2015 | Stryker Instruments Div. of Stryker Corporation 1/4 in. Curved Trocar with Wound Drain
Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound Terminated |
CAC | K970714 |
| May 1, 2015 | Stryker Instruments Div. of Stryker Corporation 1/8 in. Curved Trocar with Wound Drain
Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound Terminated |
CAC | K970714 |
| May 1, 2015 | Stryker Instruments Div. of Stryker Corporation 3/16 in. Curved Trocar with Wound Drain
Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible woun Terminated |
CAC | K970714 |
| Jul 1, 2014 | Atrium Medical Corporation Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N.
Autotransfusion Apparatus. Terminated |
CAC | K043140 K043582 |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P.
To evacuate air and/or fluid from the chest cavity or medi Terminated |
CAC | K043140 K043582 |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N.
To evacuate air and/or fluid from the chest cavity or mediastinum. Terminated |
CAC | K043140 K043582 |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100.
To evacuate air and/or fluid from the chest cavity or medias Terminated |
CAC | K043140 K043582 |
| Jan 14, 2014 | Atrium Medical Corporation Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100.
To evacuate air and/or fluid from the chest cavity or med Terminated |
CAC | K043140 K043582 |
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