510(k) K113775
- Device
- FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM
- Applicant
- OSTIAL CORPORATION
- 510(k) number
- K113775
- Product code
- LOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-06-29
- Date received
- 2011-12-22
- Regulation
- 870.5100
- Classification name
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAITLIN VON HOFFMANN
- Address
- 510 Clyde Ave. Mountain View CA US 94043 94043
FDA Registration Numbers#
- 3008573567
- 3002807315
- 3012050423
- 1028232
- 9617601
- 2183744
- 3016678045
- 2134265
- 1721686
- 3030236028
- 3015002281
- 3014390222
- 1313046
- 3014656749
- 3010220595
- 3004091615
- 9614654
- 3013546453
- 3043534762
- 9612164
- 3015910259
- 3003775186
- 3012167431
- 3004824117
- 3010273872
- 3031550970
- 3008002401
- 3004415014
- 3006946276
- 9681834
- 3009018440
- 2124215
- 3009965866
- 3002807314
- 3024893679
- 3019807891
- 3012693555
- 3014222368
- 3009205152
- 3007836437
- 3034695832
- 1000121056
- 3006550224
- 2939561
- 3011564431
- 3015453963
- 3035111606
- 3006513822
- 3003084171
- 3030421123
- 2134812
- 8043892
- 3013152301
- 3009564766
- 2011171
- 3010131137
- 9710284
- 3013634084
- 3016761372
- 3011137372
- 3007156625
- 1319639
- 3013944123
- 3010391265
- 3017961114
- 2024168
- 3008824097
- 3010432890
- 9681260
- 8010026
- 3014461810
- 3008700817
- 3017262662
- 3009613036
- 1225687
Source Documents#
Other 510(k) Records For Product Code LOX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252116 | Firefighter™ Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2026-04-07 |
| K254022 | FLASH Flex™ Aorto-Ostial Angioplasty System | Verge Medical, Inc. | 2026-04-02 |
| K252295 | Ryurei | Terumo Corporation | 2026-03-27 |
| K251970 | Sprinter Legend Rapid Exchange Balloon Dilatation Catheter | Medtronic, Ireland | 2026-01-17 |
| K242969 | Pantera Pro; Pantera LEO | Biotronik, Inc. | 2024-10-25 |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-15 |
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | Vascular Solutions, LLC | 2024-05-31 |
| K223189 | Firefighter™ NC Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | 2023-07-21 |
| K230374 | Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) | Dongguan TT Medical, Inc. | 2023-06-29 |
| K230705 | POT PTCA Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | 2023-04-11 |
| K223022 | SC HONKYTONK PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2023-02-15 |
| K222538 | NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter | Sino Medical Sciences Technology, Inc. | 2022-12-21 |
| K220634 | NC TREK NEO Coronary Dilatation Catheter | Abbott Vascular | 2022-06-30 |
| K220629 | Emerge Monorail PTCA Dilatation Catheter | Boston Scientific | 2022-03-24 |
Legacy Summary#
summary
FDA Review#
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