510(k) K032591
- Device
- NUMED TYSHAK MINI PEDIATRIC PTV CATHETER
- Applicant
- NUMED, INC.
- 510(k) number
- K032591
- Product code
- DQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-25
- Date received
- 2003-08-22
- Regulation
- 870.1250
- Classification name
- Catheter, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICHELLE R LAFLESH
- Address
- 2880 Main St. Hopkinton NY US 12965 12965
FDA Registration Numbers#
- 3008700817
- 3027058844
- 3008789872
- 3013557562
- 3022392708
- 2032112
- 3015859709
- 3016678045
- 2135147
- 3014590708
- 3027319104
- 9617601
- 3016540856
- 3000247873
- 3014461810
- 3005580113
- 3015970743
- 3003775186
- 3003910212
- 3000126629
- 3013764800
- 8010026
- 3009546466
- 3014766734
- 3012266672
- 2648729
- 3009144177
- 3017210488
- 1724474
- 1643817
- 3013134719
- 3005941719
- 3005994106
- 3016522967
- 3026788751
- 3006131984
- 3015615738
- 3008423561
- 3005168196
- 3009051888
- 2024168
- 3005718570
- 2017233
- 3044156918
- 9612164
- 1064858
- 3010155661
- 3010173425
- 3012159165
- 2027062
- 3012543881
- 8023054
- 3020954746
- 1722746
- 3005070406
- 3010419931
- 1531050
- 3007007790
- 3010665433
- 3004415014
- 9681834
- 9618000
- 3003955307
- 1018233
- 3039020025
- 8043892
- 2017865
- 2182269
- 3005635992
- 2030598
- 1647149
- 9616684
- 3002807314
- 3016171942
- 3013556777
- 3039062605
- 3004718255
- 3020347218
- 1828132
Source Documents#
Other 510(k) Records For Product Code DQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261766 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| K262240 | SSPC NXT Delivery Catheter | CenterPoint Systems, LLC | 2026-07-29 |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | Abbott | 2026-07-02 |
| K261631 | Amplatzer TorqVue Exchange System | Abbott Medical | 2026-06-17 |
| K260289 | Perfect-O Ostial Positioning Catheter | Balosmark, Inc. | 2026-06-05 |
| K260993 | Amplatzer TorqVue Delivery System | Abbott | 2026-04-24 |
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 |
| K260499 | Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL | 2026-03-13 |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Medtronic, Inc. | 2025-12-19 |
| K252417 | Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) | ABBOTT MEDICAL | 2025-12-17 |
| K252390 | Telescope Guide Extension Catheter | Medtronic, Ireland | 2025-10-29 |
| K250147 | CPS Locator 3D Delivery Catheter | Centerpoint Systems | 2025-08-22 |
| K251277 | CoraForce Microcatheter, CoraFlex Microcatheter | Reflow Medical, Inc. | 2025-08-22 |
| K250972 | Primum Hydrophilic Guiding Catheter | Pendracare | 2025-06-29 |
| K250828 | CPS Locator 3D Plus Delivery Catheter | CenterPoint Systems, LLC | 2025-06-27 |
Legacy Summary#
summary
FDA Review#
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