HeartSpan Steerable Sheath Introducer
FDA 510(k) K170668 · Merit Medical Systems, Inc.
510(k) numberK170668
Submission
- Device name
- HeartSpan Steerable Sheath Introducer
- Applicant
- Merit Medical Systems, Inc.
Malvern, PA, US - Received
- March 6, 2017
- Decision date
- April 5, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
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| K250853 | Merit SyringeFMF · Special | 11/04/2025SE |
| K251265 | Resilience Fully Covered Esophageal Stent SystemESW · Traditional | 07/23/2025SE |
| K250909 | Prelude Wave Hydrophilic Sheath IntroducerDYB · Special | 04/25/2025SE |
| K242873 | Ventrax Delivery SystemDQY · Special | 01/15/2025SE |
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Questions and answers
When was HeartSpan Steerable Sheath Introducer cleared by the FDA?
HeartSpan Steerable Sheath Introducer (K170668) received a 510(k) decision of Substantially Equivalent on April 5, 2017, 30 days after the submission was received.
What is the product code of K170668?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.