ClearanceBrief
Product code OZD ยท Class 3

Temporary Non-Roller Type Left Heart Support Blood Pump

0510(k)s in 12 months (0 all time)
14recalls in 12 months (50 all time)
0recalls that name a 510(k)
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Top companies in OZD

Company510(k)sRecalls
Abiomed, Inc.050
DateFirm and productCodeLinked 510(k)
Oct 28, 2026Abiomed, Inc.
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Open, Classified
OZDNone listed
Oct 28, 2026Abiomed, Inc.
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Open, Classified
OZDNone listed
Oct 28, 2026Abiomed, Inc.
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Open, Classified
OZDNone listed
Sep 21, 2026Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Pack
Open, Classified
OZDNone listed
Sep 16, 2026Abiomed, Inc.
Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Product Codes. 1. Optical, AIC, Impella Connect, Packaged, AU; P
Open, Classified
OZDNone listed
Sep 16, 2026Abiomed, Inc.
Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU; Product Code: 0042-0010-AU. 2. Impella Optical Controller,
Open, Classified
OZDNone listed
Sep 16, 2026Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged
Open, Classified
OZDNone listed
Jun 18, 2026Abiomed, Inc.
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Open, Classified
OZDNone listed
Jun 12, 2026Abiomed, Inc.
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-00
Open, Classified
OZDNone listed
May 28, 2026Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packa
Open, Classified
OZDNone listed
May 22, 2026Abiomed, Inc.
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Open, Classified
OZDNone listed
Mar 31, 2026Abiomed, Inc.
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code:
Open, Classified
OZDNone listed
Mar 27, 2026Abiomed, Inc.
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU;
Open, Classified
OZDNone listed
Jan 8, 2026Abiomed, Inc.
Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
Open, Classified
OZDNone listed
Oct 17, 2025Abiomed, Inc.
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Pr
Open, Classified
OZDNone listed
Oct 9, 2025Abiomed, Inc.
Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU.
Open, Classified
OZDNone listed
Sep 19, 2025Abiomed, Inc.
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Pack
Open, Classified
OZDNone listed
Jul 26, 2025Abiomed, Inc.
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella CP Smart Assist Set; Product Code: 1000402;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella 5.5 Set AU; Product Code: 1000361;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Pump 381 Pump Set (US); Product Code: 1000080;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella CP Smart Assist Set APAC; Product Code: 0048-0047;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Pump 371 14F LT CMR Set; Product Code: 0048-0045;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
Open, Classified
OZDNone listed
Sep 4, 2024Abiomed, Inc.
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
Open, Classified
OZDNone listed
Jul 17, 2024Abiomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Open, Classified
OZDNone listed
Feb 22, 2024Abiomed, Inc.
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Terminated
OZDNone listed
Feb 12, 2024Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005
Open, Classified
OZDNone listed
Feb 9, 2024Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Cod
Open, Classified
OZDNone listed
Dec 1, 2023Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Terminated
OZDNone listed
Dec 1, 2023Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
Terminated
OZDNone listed
Jul 14, 2023Abiomed, Inc.
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080
Open, Classified
OZDNone listed
Jul 14, 2023Abiomed, Inc.
Impella CP intravascular micro axial blood pump, Product Number 0048-0032
Open, Classified
OZDNone listed
Jul 14, 2023Abiomed, Inc.
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100
Open, Classified
OZDNone listed
Jul 14, 2023Abiomed, Inc.
Impella LD intravascular micro axial blood pump, Product Number 005082
Open, Classified
OZDNone listed
Jul 14, 2023Abiomed, Inc.
Impella 5.0 intravascular micro axial blood pump, Product Number 005062
Open, Classified
OZDNone listed
Jul 14, 2023Abiomed, Inc.
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
Open, Classified
OZDNone listed
May 18, 2023Abiomed, Inc.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart As
Open, Classified
OZDNone listed
Sep 4, 2019Abiomed, Inc.
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock and High-Risk PCI
Terminated
OZDNone listed

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