Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)
FDA 510(k) clearance K261529 · decided 2026-07-06
Clearance details
- K-number
- K261529
- Device name
- Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)
- Applicant
- Hartman Medical Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2026-05-08
- Decision date
- 2026-07-06
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Birmingham, AL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| NAMIC Dilator and Sheath (K253526) | Medline Industries, LP | 2026-07-29 |
| SimplGuide (K261242) | Pendracare | 2026-06-25 |
| Health Line Tearaway Introducer (K261950) | Health Line International Corporation | 2026-06-22 |
| FieldFlex Steerable Sheath (K261492) | CenterPoint Systems, LLC | 2026-06-05 |
| Echo Large Bore Introducer Sheath (K260606) | Echo Medical, LLC | 2026-04-29 |
| Introducer Sheath Set (K254248) | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| Edwards eSheath+ introducer set (K254279) | Edwards Lifesciences | 2026-04-17 |
| Aventus Introducer Sheath (K260091) | Inquis Medical | 2026-04-13 |
| Protaryx Transseptal Puncture Device (PTX2-001) (K260839) | Protaryx Medical, Inc. | 2026-04-10 |
| AuST Steerable Sheath (K260942) | CenterPoint Systems, LLC | 2026-04-07 |
| VANES Delivery System (VDS) (K260459) | Zoll Respicardia, Inc. | 2026-04-06 |
| Multiflex Steerable Sheath 17.5F (K260626) | Vizaramed, Inc. | 2026-03-26 |
Recalls involving this device
No recalls on record reference this clearance.