510(k) K223872
- Device
- Low Profile Companion Sheath
- Applicant
- Merit Medical Systems, Inc.
- 510(k) number
- K223872
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-19
- Date received
- 2022-12-23
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kirk McIntosh
- Address
- 1600 W. Merit Pkwy. South Jordan UT US 84095 84095
FDA Registration Numbers#
- 3008998256
- 3004785273
- 3004519921
- 3013557562
- 2032112
- 3015859709
- 3016678045
- 1824619
- 3010391198
- 1649395
- 2030404
- 3013400708
- 3005580113
- 9673241
- 3015970743
- 3013300026
- 3016986313
- 8010026
- 3013764800
- 3009746061
- 3017060084
- 3009144177
- 3015173212
- 1724474
- 1643817
- 3008500478
- 3007697249
- 3005941719
- 2320762
- 3005994106
- 3006131984
- 3009393076
- 3015615738
- 9612126
- 1220648
- 1055236
- 3005168196
- 3036802499
- 1423537
- 2024168
- 3013986346
- 3015138222
- 9612164
- 3007830707
- 1064858
- 3010155661
- 3041086754
- 3008002401
- 2248146
- 3020954746
- 1722746
- 3010419931
- 3010665433
- 3007695959
- 9681834
- 1018233
- 2182269
- 8043892
- 1625685
- 2017865
- 2030598
- 1647149
- 2025816
- 2090040
- 9610847
- 1319211
- 3002807314
- 3020347218
- 1710034
- 2183744
- 1417485
- 1650907
- 3030574705
- 3017689643
- 3001374820
- 9616666
- 3002808467
- 3027366703
- 2134265
Source Documents#
Other 510(k) Records For Product Code DYB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026-07-29 |
| K261529 | 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) | Hartman Medical Group, LLC | 2026-07-06 |
| K261242 | SimplGuide | Pendracare | 2026-06-25 |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026-06-22 |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026-06-05 |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026-04-29 |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | 2026-04-17 |
| K260091 | Aventus Introducer Sheath | Inquis Medical | 2026-04-13 |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026-04-10 |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026-04-07 |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026-04-06 |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026-03-26 |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026-02-19 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 |