510(k) K243954
- Device
- PeriCross? Epicardial Access Kit
- Applicant
- Circa Scientific, Inc.
- 510(k) number
- K243954
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-24
- Date received
- 2024-12-23
- Regulation
- 870.1340
- Classification name
- Introducer, Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alice Ouyang
- Address
- 14 Inverness Dr. E, Suite H-136 Englewood CO US 80112 80112
FDA Registration Numbers#
- 9610825
- 3031823122
- 1721676
- 3015859709
- 3015138222
- 9610847
- 2024168
- 1319211
- 3037050339
- 3013288201
- 2518902
- 3030446844
- 1721504
- 3007603855
- 3037047821
- 3010419931
- 2030404
- 3009888344
- 3013162291
- 3007882731
- 9681477
- 9673241
- 3004784537
- 3007830707
- 2020394
- 3009393076
- 3004091615
- 3015173212
- 3021951050
- 1650907
- 3032916632
- 3003610571
- 3006283319
- 1649395
- 2134265
- 9614279
- 3030733800
- 1647149
- 3020954746
- 3013666336
- 3043337628
- 9617592
- 3005941719
- 3008452825
- 3005994106
- 3004134316
- 3007695959
- 3007284313
- 3046772394
- 2015691
- 1282497
- 3020347218
- 2024311
- 3022815697
- 2648045
- 2017865
- 2029015
- 3003898360
- 3017168767
- 2528981
- 1223004
- 1055236
- 9616088
- 9612126
- 3010421104
- 3035111606
- 3008500478
- 8020785
- 3017636737
- 9611612
- 3017689643
- 3002807314
- 3002808467
- 1526863
- 3011063223
- 9681834
- 3031571797
- 3005168196
- 3004737415
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 |