510(k) K251402
- Device
- LIA-1 Catheter (542-1)
- Applicant
- Leadoptik, Inc.
- 510(k) number
- K251402
- Product code
- KTI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-19
- Date received
- 2025-05-06
- Regulation
- 874.4680
- Classification name
- Bronchoscope Accessory
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mohammadreza Khorasaninejad
- Address
- 2380 Qume Dr. Suite A San Jose CA US 95131 95131
FDA Registration Numbers#
- 1018470
- 3014769442
- 2183744
- 9611102
- 3007695959
- 9710524
- 3003418325
- 3014749926
- 3008797804
- 3012422952
- 9616684
- 3026787544
- 3004837686
- 3015309643
- 1223925
- 3012266672
- 3006950086
- 3003477135
- 1320894
- 3016548968
- 3008058134
- 1651395
- 3005172759
- 3012042439
- 3010273872
- 2183446
- 3003790304
- 3033589330
- 3015970743
- 3042970803
- 3005423519
- 3005099803
- 3002807314
- 3007305485
- 1721676
- 3008040402
- 1721504
- 1000121056
- 3014579161
- 9614641
- 8010047
- 3011050570
- 1724474
- 1047843
- 3002907620
- 3013152301
- 3013517171
- 3008087383
- 1820334
- 3005803389
- 3015225571
- 3010188783
- 3013440400
- 3012494290
- 3012536737
- 3013557562
- 1043729
- 3003678543
- 9681260
- 8040233
- 1928237
- 3015980719
- 3021230784
- 3013023255
Source Documents#
Other 510(k) Records For Product Code KTI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251478 | ClearTip TBNA Type | Finemedix Co., Ltd. | 2026-04-16 |
| K254040 | LungFlow Basket Catheter | Free Flow Medical, Inc. | 2026-03-12 |
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | 2025-10-08 |
| K251664 | Single Use Aspiration Needle (NA-201SX-4021); Single Use Aspiration Needle (NA-201SX-4022) | Olympus Medical Systems Corporation | 2025-07-29 |
| K250263 | Disposable Grasping Forceps FG-52D/FG-54D | Olympus Medical Systems Corp. | 2025-03-31 |
| K241679 | Disposable Cytology Brush (AF series) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-03-04 |
| K231818 | METIC™- Airway Balloon Catheter | M/S Meril Life Sciences Pvt. , Ltd. | 2023-11-15 |
| K230778 | EndoCore | Praxis Medical, LLC | 2023-09-25 |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | Ga Health Company Limited | 2023-05-11 |
| K222187 | Multistage Balloon Dilatation Catheter | Dongguan TT Medical, Inc. | 2023-03-01 |
| K221206 | Compass Steerable Needle | Serpex Medical, Inc. | 2022-08-25 |
| K213060 | AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-20 |
| K213434 | Elation Pulmonary Balloon Dilation Catheter | Merit Medical Systems, Inc. | 2022-03-08 |
| K211894 | Trachealator | Disa Medinotec | 2021-11-24 |
| K193517 | ViziShot 2 FLEX | Olympus Surgical Technologies America | 2020-03-18 |