HeartSpan Steerable Introducer Kit
by Merit Medical Systems, Inc.
510(k) K132164
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK132164 | Date17 Sep 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DYB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The HeartSpan Steerable Introducer Kit is a steerable sheath introducer set designed for catheter introduction into the cardiac anatomy. It consists of a dilator, guide wire, and steerable sheath, and includes a hemostasis valve to minimize blood loss during catheter introduction and/or exchange.
The device is supplied as a kit and is intended for use in cardiovascular procedures. It is a single-use device, and its authorization is based on FDA 510(k) clearance under product code DYB, with a determination of substantial equivalence.
From the manufacturer
HeartSpan Steerable Sheath Introducer - control, coverage and comfort with a softer atraumatic tip and bidirectional 180 degree deflection.
INSTRUCTIONS FOR USE Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions noted in these directions. Failure to do so may result in patient complications. Merit Medical Systems, Inc. relies on the physician to determine, assess, and communicate to each patient all foreseeable risks of the procedure.
DESCRIPTION The HeartSpan Steerable Sheath Introducer set consists of a dilator, guide wire, and steerable sheath, which are designed for catheter introduction into the cardiac anatomy. The steerable introducer contains a hemostasis valve to minimize blood loss during catheter introduction and/or exchange.
Other devices from Merit Medical Systems, Inc.
Questions
AI-generated answers, 28 Sep 2026
What is the HeartSpan Steerable Introducer Kit used for?
The HeartSpan Steerable Introducer Kit is designed for catheter introduction into the cardiac anatomy during cardiovascular procedures, facilitating access and exchange while minimizing blood loss via its hemostasis valve.
Is the HeartSpan Steerable Introducer Kit reusable or single-use?
The device is explicitly labeled as a single-use device, meaning it is intended for one procedure only and should not be reprocessed or reused to ensure patient safety and device integrity.
What components are included in the HeartSpan Steerable Introducer Kit?
The kit includes a steerable sheath, a dilator, a guide wire, and a hemostasis valve, all working together to enable controlled catheter introduction and exchange in cardiac anatomy while reducing blood loss.
How is the HeartSpan Steerable Introducer Kit supplied and stored?
The device is supplied as a sterile, single-use kit and should be stored in accordance with the manufacturer’s instructions, typically in a clean, dry environment at controlled room temperature until use.