Atlas FDA

ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD

FDA 510(k) clearance K011056 · decided 2001-10-24

Clearance details

K-number
K011056
Device name
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
2001-04-06
Decision date
2001-10-24
Days to decision
201 days
Clearance type
Traditional
Product code
QEW
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Reading, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, recall (Z-0623-2022)TELEFLEX MEDICAL INC2022-02-15
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC recall (Z-0624-2022)TELEFLEX MEDICAL INC2022-02-15
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W co recall (Z-0625-2022)TELEFLEX MEDICAL INC2022-02-15
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC c recall (Z-0626-2022)TELEFLEX MEDICAL INC2022-02-15
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components recall (Z-0627-2022)TELEFLEX MEDICAL INC2022-02-15
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC recall (Z-0628-2022)TELEFLEX MEDICAL INC2022-02-15
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good ki recall (Z-0629-2022)TELEFLEX MEDICAL INC2022-02-15
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: recall (Z-0231-2022)Arrow International Inc2021-11-18
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: recall (Z-0232-2022)Arrow International Inc2021-11-18
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: recall (Z-0233-2022)Arrow International Inc2021-11-18
Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: recall (Z-0234-2022)Arrow International Inc2021-11-18
Arrow OTW Percutaneous Thrombolytic Device (PTD) for fistulae and dialysis grafts recall (Z-1502-2009)Arrow International Inc2009-06-24
The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709 recall (Z-0842-05)Arrow International Inc2005-05-13