Home › Device types › KRA
Catheter, Continuous Flush
FDA product code KRA · Class 2 · Cardiovascular
1,823
Registered devices
8,965
Adverse events
96
Recalls
175
510(k) clearances
Devices with this code
Solitaire™ X-PACK — Micro Therapeutics, Inc.TRUWAVE,VAMP PLUS — Edwards Lifesciences LLCPulseSpray — Angiodynamics, Inc.Fountain® — Merit Medical Systems, Inc.EXCELSIOR XT-27 — Stryker CorporationRenegade™ HI-FLO™ — BOSTON SCIENTIFIC CORPORATIONFountain® — Merit Medical Systems, Inc.PulseSpray — Angiodynamics, Inc.UniFuse — Angiodynamics, Inc.Triever 24 — Inari Medical, Inc.PROWLER SELECT — Medos International SàrlEkoSonic® — BOSTON SCIENTIFIC CORPORATIONFountain® — Merit Medical Systems, Inc.Finesse BTK Multicath — Summa Therapeutics, LLCFountain® — Merit Medical Systems, Inc.ICU Medical — ICU MEDICAL, INC.Solitaire™ X-PACK — Micro Therapeutics, Inc.TRUSELECT™ — BOSTON SCIENTIFIC CORPORATIONNeVa pVasc 6.0 x 44 mm - Flow Restoration, 3 Drop Zones - 180 cm wire System — VesalioTRUWAVE, VAMP JR. — Edwards Lifesciences LLCPhenomTM Plus Catheter — Micro Therapeutics, Inc.Direxion™ HI-FLO™ — BOSTON SCIENTIFIC CORPORATIONRenegade™ HI-FLO™ Kit — BOSTON SCIENTIFIC CORPORATIONVAMP — Edwards Lifesciences LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-18 | Angiodynamics, Inc. | Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication. |
| 2023-11-06 | Merit Medical Systems, Inc. | The sterility of microcatheter and infusion system devices cannot be guaranteed. |
| 2022-06-30 | Micro Therapeutics, Inc. | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| 2022-06-30 | Micro Therapeutics, Inc. | Outer carton packaging of microcatheters were exposed to wet substance during transport. |
| 2020-11-03 | Boston Scientific Corporation | This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal boar |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) an |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) an |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) an |
| 2019-11-08 | Cook Inc. | A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) an |
| 2017-11-09 | Vascular Insights, LLC | Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including |
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