Atlas FDA

FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET

FDA 510(k) clearance K140110 · decided 2015-03-27

Clearance details

K-number
K140110
Device name
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET
Applicant
Teleflex, Inc.
Decision
Substantially Equivalent
Date received
2014-01-15
Decision date
2015-03-27
Days to decision
436 days
Clearance type
Traditional
Product code
BSO
Device class
2
Regulation number
868.5120
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Reading, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZAT recall (Z-2371-2026)ARROW INTERNATIONAL, LLC2026-06-13
FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET recall (Z-1913-2026)ARROW INTERNATIONAL, LLC2026-04-22
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05501 recall (Z-1172-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH recall (Z-1174-2020)Arrow International Inc2020-01-24
FlexTip Plus Epidural Catheterization Kit, Product Code AK-05500 recall (Z-1177-2020)Arrow International Inc2020-01-24