510(k) K913746
- Device
- SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM
- Applicant
- PERIPHERAL SYSTEMS GROUP
- 510(k) number
- K913746
- Product code
- ITX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-12-17
- Date received
- 1991-08-21
- Regulation
- 892.1570
- Classification name
- Transducer, Ultrasonic, Diagnostic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JESSICA AYRES
- Address
- 1395 Charleston Rd. Mountain View CA US 94043 94043
FDA Registration Numbers#
- 2954783
- 3006441164
- 3031851875
- 8010047
- 1060680
- 3013844297
- 3003851073
- 3010041511
- 3010432890
- 3031397684
- 3017944270
- 3013757696
- 3003637092
- 3009436116
- 2030624
- 3043534483
- 3011200896
- 2183319
- 3007603826
- 1000601180
- 3008921662
- 1126271
- 1000391004
- 1930027
- 3003971136
- 3042225166
- 3010389834
- 3040391009
- 3012316249
- 8030392
- 9615439
- 3019216
- 1000589001
- 3031259044
- 3032109181
- 3004574050
- 3012402886
- 3042470731
- 3008363989
- 3011686611
- 1820334
- 1720929
- 1528319
- 3025429169
- 3011106828
- 3015531959
- 3007194257
- 1937397
- 3013557562
- 1416980
- 3006540052
- 3009247326
- 3010663777
- 2531814
- 9616774
- 2938651
- 1417592
- 3008386005
- 3033275035
- 3017487805
- 1066270
- 3029744051
- 3010220244
- 3021226419
- 8043385
- 3032008018
- 1216677
- 3016171942
- 3012747207
- 3035373446
- 3003995932
- 3014639846
- 9611031
- 9615849
- 3007544634
- 3009077524
- 3004727093
- 3003832357
- 3005210579
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ITX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250883 | ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R) | Olympus Medical Systems Corporation | 2025-09-18 |
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Olympus Medical Systems Corporation | 2025-07-11 |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | 2025-07-02 |
| K250469 | Accuro® 3S Needle Guide Kit | Rivanna Medical, Inc. | 2025-06-13 |
| K241662 | Ultrasound Transducer Cover | Vitrolife Sweden AB | 2024-08-30 |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Parker Laboratories, Inc. | 2024-08-15 |
| K241615 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2024-07-03 |
| K233109 | TP Pivot Pro™ Needle Guide | Civco Medical Solutions | 2023-12-22 |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | 2023-12-13 |
| K231783 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2023-11-14 |
| K223689 | Disposable Needle Guides and Grids | Advance Medical Designs, Inc. | 2023-08-02 |
| K222460 | Intraoperative Ultrasound Probe Cover | Exact Medical Manufacturing | 2023-05-12 |
| K221278 | Transducer Probe Cover | Hony Medical Co., Ltd. | 2023-01-11 |
| K222052 | VitroPRO | CIVCO Medical Instruments Co., Inc. | 2022-11-22 |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Global Protection Corp. | 2022-06-07 |
Legacy Summary#
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FDA Review#
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