Halo One Thin-Walled Guiding Sheath
FDA 510(k) K192313 · C.R. Bard, Inc.
510(k) numberK192313
Submission
- Device name
- Halo One Thin-Walled Guiding Sheath
- Applicant
- C.R. Bard, Inc.
Enniscorthy, IE - Received
- August 26, 2019
- Decision date
- December 19, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
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| 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 |
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| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
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| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
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Questions and answers
When was Halo One Thin-Walled Guiding Sheath cleared by the FDA?
Halo One Thin-Walled Guiding Sheath (K192313) received a 510(k) decision of Substantially Equivalent on December 19, 2019, 115 days after the submission was received.
What is the product code of K192313?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.