510(k) K232594
- Device
- CATHTONG II PICC Catheter
- Applicant
- L&Z Us, Inc.
- 510(k) number
- K232594
- Product code
- LJS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-22
- Date received
- 2023-08-25
- Regulation
- 880.5970
- Classification name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- James Li
- Address
- 49 Walnut St. Unit 1 Norwood NJ US 07648 07648
FDA Registration Numbers
- 3004134316
- 3007697249
- 3010827261
- 9617592
- 1061124
- 2183744
- 3012536737
- 3007137787
- 3010882065
- 3006260740
- 1644312
- 3021570645
- 1833566
- 3005636544
- 3013233645
- 1718873
- 3013557562
- 2246552
- 2133772
- 1423537
- 1721676
- 1820334
- 3006425876
- 3013750125
- 3012307300
- 3013788631
- 3006950086
- 3033589330
- 3013162291
- 3003915875
- 1018233
- 3013666218
- 1625425
- 3035111606
- 1000484830
- 3030714660
- 3015060216
- 3004753388
- 1722746
- 3013501772
- 3015537049
- 3011534620
- 1724474
- 3015859709
- 1319639
- 3016727301
- 3038181770
- 3013041594
- 2245270
- 9681477
- 3006942602
- 3007207906
- 2030624
- 3007544874
- 3016472589
- 1921846
- 1647149
- 1223004
- 3009888344
- 3005704822
- 1220477
- 3030148766
- 1000314502
- 3011237770
- 1643817
- 3003898360
- 1721686
- 1225492
- 9681202
- 1048735
- 3004111573
- 1424778
- 2518902
- 9612433
- 3010041511
- 1319211
- 2527072
- 3024673
- 9680794
- 3009211636
- 3010532612
- 3015225571
- 3006082230
- 3010882708
- 3011137372
- 3015309643
- 2011171
- 1721504
- 9617604
- 1219930
- 3018094310
Source Documents
510(k) summary PDF not indicated by FDA
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