510(k) K032569
- Device
- SHORT INTRODUCER SHEATH
- Applicant
- REX MEDICAL
- 510(k) number
- K032569
- Product code
- DYB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-16
- Date received
- 2003-08-20
- 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
- SUSAN D GOLDSTEIN-FALK
- Address
- 55 Northern Blvd., Suite 200 Great Neck NY US 11021 11021
FDA Registration Numbers#
- 9681834
- 3020283264
- 3019807891
- 2518902
- 1644312
- 9681477
- 3017298588
- 3016986313
- 1282497
- 2024311
- 3008307705
- 3005580113
- 3010882708
- 9616099
- 1000393132
- 1319639
- 2320762
- 1054241
- 2528981
- 3020954746
- 3015859709
- 3020968442
- 2020394
- 3004784537
- 9681260
- 1000563940
- 3012179728
- 3006425876
- 3003915875
- 3003898360
- 1223004
- 3015173212
- 1722746
- 3007695959
- 3011642792
- 3014687026
- 9610847
- 9616088
- 3030236028
- 3014656749
- 3006082230
- 9616683
- 1220648
- 9617465
- 3005941719
- 3013758550
- 1224960
- 3041086754
- 3015970743
- 3010419931
- 3009211636
- 1721676
- 2953200
- 3025028711
- 3008452825
- 1424263
- 3033589330
- 2030404
- 1000121056
- 3009905888
- 1422634
- 3004785273
- 1055236
- 3045178474
- 3005334138
- 1064858
- 9673241
- 2025816
- 3017406698
- 3031571797
- 2017865
- 3007830707
- 3011623145
- 3010432890
- 3010220595
- 1319211
- 3007882731
- 1318694
- 3004111573
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 |
Legacy Summary#
summary
FDA Review#
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