HDC Vadd (Vascular Access Device) Tunneler
FDA 510(k) K951098 · Hdc Corp.
510(k) numberK951098
Submission
- Device name
- HDC Vadd (Vascular Access Device) Tunneler
- Applicant
- Hdc Corp.
San Jose, CA, US - Received
- March 9, 1995
- Decision date
- June 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5970
- Specialty
- General Hospital
- Implant
- Yes
Other 510(k)s with product code LJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260929 | Neonav ECG Tip Location SystemLJS · Special | Navi Medical Technologies | 04/17/2026SE |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with…LJS · Traditional | Spectrum Vascular | 12/16/2025SE |
| K252792 | PM2 System with ECGuide ConnectorLJS · Special | Piccolo Medical, Inc. | 11/17/2025SE |
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301)…LJS · Traditional | Access Vascular, Inc. | 08/01/2025SE |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC…LJS · Special | Access Vascular, Inc. | 07/01/2025SE |
| K243484 | PM2+ System and SmartPICC StyletLJS · Traditional | Piccolo Medical, Inc. | 05/29/2025SE |
| K241587 | pilot TLSLJS · Traditional | Vygon Corporation | 02/26/2025SE |
| K241910 | Neonav ECG Tip Location SystemLJS · Traditional | Navi Medical Technologies | 01/19/2025SE |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201)…LJS · Special | Access Vascular, Inc. | 01/17/2025SE |
| K240486 | PM2 System and ECGuide ConnectorLJS · Traditional | Piccolo Medical, Inc. | 09/08/2024SE |
More from Piccolo Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071875 | V-Cath Poly PiccLJS · Traditional | 11/05/2007SE |
| K023342 | Neuro-Trace III Kit, Neuro-Trace III Regional Block Cable, Neuro-Trace III Nerve Mapping…KOI · Traditional | 03/02/2004SE |
| K033853 | Modification to V-Cath Poly PiccFOZ · Special | 01/14/2004SE |
| K032404 | Seldinger Safety Needle IntroducerDYB · Special | 09/10/2003SE |
| K022752 | Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15…CAZ · Traditional | 09/09/2003SE |
| K022099 | Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'SFOZ · Traditional | 09/20/2002SE |
| K010425 | Epidural Catheter with Connector (and Accessory)KNF · Special | 03/15/2001SE |
| K994059 | Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07CAZ · Traditional | 10/13/2000SE |
| K002770 | Ibis Chemo-Port Implantable Vascular Access System, Model…LJT · Special | 09/26/2000SE |
| K983119 | Entero-Test HP, Model #102-01LIO · Traditional | 03/15/1999SE |
Questions and answers
When was HDC Vadd (Vascular Access Device) Tunneler cleared by the FDA?
HDC Vadd (Vascular Access Device) Tunneler (K951098) received a 510(k) decision of Substantially Equivalent on June 2, 1995, 85 days after the submission was received.
What is the product code of K951098?
The FDA product code is LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5970.