Home › Device types › DYB
Introducer, Catheter
FDA product code DYB · Class 2 · Cardiovascular
11,671
Registered devices
41,696
Adverse events
389
Recalls
706
510(k) clearances
Devices with this code
Demax — Beijing Demax Medical Technology Co., Ltd.ARROW — TELEFLEX INCORPORATEDOptiSeal™ — Greatbatch LtdOptiSeal™ — Greatbatch LtdVersaCross Access Solution — Baylis Médicale Cie IncDemax — Beijing Demax Medical Technology Co., Ltd.Demax — Beijing Demax Medical Technology Co., Ltd.SOLOPATH — ONSET MEDICAL CORPORATIONFlexor — COOK INCORPORATEDSOLOPATH — TERUMO MEDICAL CORPORATIONARROW — TELEFLEX INCORPORATEDGORE® DrySeal Flex Introducer Sheath — W. L. Gore & Associates, Inc.MICRO-STICK SET — JET MEDICAL, INC.Demax — Beijing Demax Medical Technology Co., Ltd.ARROW — TELEFLEX INCORPORATEDTorFlex Transseptal Guiding Sheath — Baylis Médicale Cie IncPrelude EASE™ — Merit Medical Systems, Inc.TourGuide™ Steerable Sheath — Oscor Inc.COMPASS ™ — B BRAUN INTERVENTIONAL SYSTEMS, INCDemax — Beijing Demax Medical Technology Co., Ltd.OptiSeal™ — Greatbatch LtdNA — B BRAUN INTERVENTIONAL SYSTEMS, INCPathBuilder Transseptal Guiding Introducer — Shanghai Microport Ep Medtech Co., Ltd.ARROW — TELEFLEX INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-15 | Terumo Medical Corporation | Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing |
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