888 Arterial/Venous Catheter Introducer
FDA 510(k) K771982 · Usci, Div. C.R. Bard, Inc.
510(k) numberK771982
Submission
- Device name
- 888 Arterial/Venous Catheter Introducer
- Applicant
- Usci, Div. C.R. Bard, Inc.
Mchenry, IL, US - Received
- October 18, 1977
- Decision date
- November 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940092 | Usci Input Introducer SetDYB · Traditional | 08/10/1995SE |
| K884209 | Usci Dorros Infusion/Probing CatheterDQY · Traditional | 12/21/1988SE |
| K771823 | Catheter, CardiovascularDYG · Traditional | 12/20/1977SE |
| K772021 | TRC Stainless Steel Safety Spring GuidesDQX · Traditional | 11/02/1977SE |
| K770835 | Patch FabricDXZ · Traditional | 10/05/1977SE |
| K770561 | Catheter,Percutaneous Introduc. & SheathDYB · Traditional | 04/26/1977SE |
| K770236 | Sauvage Filamentous ProsthesesDSY · Traditional | 02/25/1977SE |
| K770235 | Debakey Vasculour-D ProsthesesDSY · Traditional | 02/24/1977SE |
| K760843 | Paley Transparent ManifoldDTL · Traditional | 11/12/1976SE |
| K760403 | Temporary Atrial Electrode KitDRE · Traditional | 08/23/1976SE |
Questions and answers
When was 888 Arterial/Venous Catheter Introducer cleared by the FDA?
888 Arterial/Venous Catheter Introducer (K771982) received a 510(k) decision of Substantially Equivalent on November 2, 1977, 15 days after the submission was received.
What is the product code of K771982?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.