510(k) K211910
- Device
- Z-6 Atrioseptostomy Catheter
- Applicant
- NuMED, Inc.
- 510(k) number
- K211910
- Product code
- DXF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-07-19
- Date received
- 2021-06-21
- Regulation
- 870.5175
- Classification name
- Catheter, Septostomy
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nichelle LaFlesh
- Address
- 2880 Main St. Hopkinton NY US 12965 12965
FDA Registration Numbers#
- 1047843
- 3013666336
- 3040993693
- 1424785
- 3013986346
- 1225687
- 1319639
- 3029895042
- 3020968442
- 2528981
- 9618000
- 3009437315
- 1424263
- 3012833053
- 1000121056
- 3019751610
- 3010273872
- 1820334
- 1318694
- 2030624
- 3025341484
- 2015691
- 2124215
- 2183744
- 2126666
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DXF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC | 2026-03-13 |
| K260292 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical | 2026-02-27 |
| K252419 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical, Inc. | 2025-08-27 |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) | Circa Scientific, Inc. | 2025-05-01 |
| K243193 | Cross Wise™ Multi-Use RF Adapter Cable | Circa Scientific, Inc. | 2024-11-26 |
| K242076 | VersaCross™ RF Wire | Baylis Medical Company | 2024-11-01 |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) | Circa Scientific, Inc. | 2024-09-26 |
| K240900 | HOTWIRE™ RF Guidewire | Atraverse Medical | 2024-05-01 |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable | Cross Vascular, Inc. | 2023-10-12 |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | Edwards Lifesciences, LLC | 2022-08-22 |
| K182399 | Park Blade Septostomy Catheter | Cook Incorporated | 2019-04-04 |
| K150709 | ProTrack RF Anchor Wire | Baylis Medical Company, Inc. | 2015-06-17 |
| K073326 | NRG TRANSSEPTAL NEEDLE | Baylis Medical Co., Inc. | 2008-05-28 |
| K031949 | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 | Baylis Medical Co., Inc. | 2003-12-10 |
| K011557 | PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS | NuMED, Inc. | 2001-07-12 |
Legacy Summary#
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FDA Review#
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