510(k) K021142
- Device
- ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
- Applicant
- Fortune Medical Instrument Corp.
- 510(k) number
- K021142
- Product code
- EZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-10-01
- Date received
- 2002-04-09
- Regulation
- 876.5130
- Classification name
- Catheter, Retention Type, Balloon
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- TYLER WANG
- Address
- 12-9, Lin 5, Mao-Chang Village San-Chih Hsiang Taipei Hsien TW 252 252
FDA Registration Numbers#
- 8022978
- 3038139564
- 3012649202
- 1825146
- 3009057691
- 3009086335
- 1018233
- 3007798534
- 9611712
- 2011171
- 9612030
- 1061124
- 3000247987
- 3015337348
- 3005515211
- 3008806809
- 3003477135
- 3007156625
- 9610711
- 3010131137
- 3015173212
- 1314417
- 3004111573
- 3011252788
- 3010400865
- 2030624
- 3029906222
- 3011383638
- 3010220595
- 3001124136
- 2320762
- 1054241
- 3031190571
- 3020978007
- 3016738724
- 3005483737
- 1650927
- 3003965134
- 8040607
- 3011987967
- 3031175043
- 3005669815
- 1928237
- 3014650073
- 3002907620
- 3004070478
- 8043983
- 1043214
- 3012421607
- 8040412
- 3012104670
- 1820334
- 3027547323
- 3027301746
- 9616567
- 3013369910
- 3015176887
- 3030970103
- 3008959444
- 3030089838
- 2432320
- 1921846
- 3005012805
- 3000308637
- 1058584
- 3013557562
- 3016904853
- 1055236
- 3006787036
- 3043051314
- 3008502431
- 3011137372
- 3005609751
- 1649518
- 1417592
- 3014579161
- 3016618143
- 3016761372
- 3006621386
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EZL#
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| K222118 | 2-Way 100% Silicone Cleartract Catheter | Silq Technologies, Corp. | 2022-12-01 |
| K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | 2022-07-01 |
| K212151 | FLUME catheter | The Flume Catheter Company, Ltd. | 2021-11-03 |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | 2021-04-08 |
| K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | 2020-12-30 |