Atlas FDA

TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)

FDA 510(k) clearance K072625 · decided 2007-12-13

Clearance details

K-number
K072625
Device name
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
Applicant
Cook, Inc.
Decision
Substantially Equivalent
Date received
2007-09-17
Decision date
2007-12-13
Days to decision
87 days
Clearance type
Traditional
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Bloomington, IN, US
Third-party review
No
Expedited review
No

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pilot TLS (K241587)Vygon Corporation2025-02-26
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Recalls involving this device

RecordFirmDate
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1181-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1182-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1183-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1184-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1185-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1186-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1187-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1188-2011)Cook, Inc.2011-02-23
Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous recall (Z-1189-2011)Cook, Inc.2011-02-23

PMA approvals by this applicant

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Zenith Fenestrated AAA Endovascular Graft (P020018/S063)Cook, Inc.2024-04-29
Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061)Cook, Inc.2023-12-14
Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062)Cook, Inc.2023-12-13
Zenith Fenestrated AAA Endovascular Graft (P020018/S060)Cook, Inc.2022-01-20
Zenith AAA Endovascular Graft (P020018/S059)Cook, Inc.2020-10-08
ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055)Cook, Inc.2018-10-10