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)
Top companies in OZD
| Company | 510(k)s | Recalls |
|---|---|---|
| Abiomed, Inc. | 0 | 50 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2026 | Abiomed, Inc. Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump. Open, Classified |
OZD | None listed |
| Oct 28, 2026 | Abiomed, Inc. Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump. Open, Classified |
OZD | None listed |
| Oct 28, 2026 | Abiomed, Inc. Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump. Open, Classified |
OZD | None listed |
| Sep 21, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Abiomed, 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 |
OZD | None listed |
| Sep 16, 2026 | Abiomed, 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 |
OZD | None listed |
| Jun 18, 2026 | Abiomed, Inc. Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. Open, Classified |
OZD | None listed |
| Jun 12, 2026 | Abiomed, 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 |
OZD | None listed |
| May 28, 2026 | Abiomed, 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 |
OZD | None listed |
| May 22, 2026 | Abiomed, Inc. Automated Impella Controller (AIC);
Product Code: 0042-0000-US; Open, Classified |
OZD | None listed |
| Mar 31, 2026 | Abiomed, 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 |
OZD | None listed |
| Mar 27, 2026 | Abiomed, 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 |
OZD | None listed |
| Jan 8, 2026 | Abiomed, Inc. Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU. Open, Classified |
OZD | None listed |
| Oct 17, 2025 | Abiomed, 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 |
OZD | None listed |
| Oct 9, 2025 | Abiomed, 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 |
OZD | None listed |
| Sep 19, 2025 | Abiomed, 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 |
OZD | None listed |
| Jul 26, 2025 | Abiomed, 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 |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella CP Smart Assist Set; Product Code: 1000402; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 Set AU; Product Code: 1000361; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Pump 381 Pump Set (US); Product Code: 1000080; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella CP Smart Assist Set APAC; Product Code: 0048-0047; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Pump 371 14F LT CMR Set; Product Code: 0048-0045; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; Open, Classified |
OZD | None listed |
| Sep 4, 2024 | Abiomed, Inc. Impella CP Smart Assist Set, EU; Product Code: 0048-0014; Open, Classified |
OZD | None listed |
| Jul 17, 2024 | Abiomed, Inc. Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump Open, Classified |
OZD | None listed |
| Feb 22, 2024 | Abiomed, Inc. Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular) Terminated |
OZD | None listed |
| Feb 12, 2024 | Abiomed, 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 |
OZD | None listed |
| Feb 9, 2024 | Abiomed, 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 |
OZD | None listed |
| Dec 1, 2023 | Abiomed, Inc. Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1. Terminated |
OZD | None listed |
| Dec 1, 2023 | Abiomed, Inc. Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1. Terminated |
OZD | None listed |
| Jul 14, 2023 | Abiomed, Inc. Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-0045, 1000080 Open, Classified |
OZD | None listed |
| Jul 14, 2023 | Abiomed, Inc. Impella CP intravascular micro axial blood pump, Product Number 0048-0032 Open, Classified |
OZD | None listed |
| Jul 14, 2023 | Abiomed, Inc. Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 1000100 Open, Classified |
OZD | None listed |
| Jul 14, 2023 | Abiomed, Inc. Impella LD intravascular micro axial blood pump, Product Number 005082 Open, Classified |
OZD | None listed |
| Jul 14, 2023 | Abiomed, Inc. Impella 5.0 intravascular micro axial blood pump, Product Number 005062 Open, Classified |
OZD | None listed |
| Jul 14, 2023 | Abiomed, Inc. Impella 2.5 intravascular micro axial blood pump, Product Number 005042 Open, Classified |
OZD | None listed |
| May 18, 2023 | Abiomed, 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 |
OZD | None listed |
| Sep 4, 2019 | Abiomed, 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 |
OZD | None listed |
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