510(k) K023595
- Device
- BURETTE-IN LINE (150 ML)
- Applicant
- Tuta Healthcare Pty Limited
- 510(k) number
- K023595
- Product code
- FPA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-12-18
- Date received
- 2002-10-28
- Regulation
- 880.5440
- Classification name
- Set, Administration, Intravascular
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- OMID SOURESRAFIL
- Address
- 318-332 Burns Bay Rd. Ln. Cove Sydney Nsw AU 2066 2066
FDA Registration Numbers#
- 1000304305
- 1016427
- 1320894
- 3010432890
- 2011068
- 3006950086
- 9612152
- 3011137372
- 9681572
- 1721686
- 3018071447
- 3012187973
- 3016096098
- 3011237770
- 1220905
- 3010882065
- 3012809732
- 3008328679
- 3003310007
- 3045322464
- 3008808123
- 2032521
- 1721504
- 3043226252
- 3018229072
- 9615817
- 3016798778
- 3005669815
- 9680306
- 1820334
- 3004194523
- 2320762
- 9615588
- 3009882464
- 1720929
- 1723241
- 1649914
- 3022964615
- 3013764800
- 3044026004
- 3005515211
- 9617475
- 9680222
- 2248588
- 3008403546
- 3010830834
- 9615908
- 3000247873
- 3017636737
- 3004605321
- 1423537
- 1450662
- 3015983454
- 8041145
- 3013319212
- 3004111573
- 1037885
- 1055236
- 2648727
- 3003704957
- 3030447506
- 2011171
- 3012494290
- 3012429465
- 3010082909
- 3007305485
- 3015910259
- 1063382
- 3029973819
- 1061124
- 3008588205
- 3002296055
- 9680787
- 1417592
- 1833470
- 3015140199
- 1319660
- 3010291427
- 2032227
Source Documents#
Other 510(k) Records For Product Code FPA#
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| K250616 | Clave™ Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | 2025-06-05 |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025-05-09 |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | 2025-05-02 |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025-03-14 |