Solo Picc/Midline Catheter Kit Models 71924, 71908
FDA 510(k) K961155 · Douglas Medical Products Corp.
510(k) numberK961155
Submission
- Device name
- Solo Picc/Midline Catheter Kit Models 71924, 71908
- Applicant
- Douglas Medical Products Corp.
Libertyville, IL, US - Received
- March 22, 1996
- Decision date
- June 18, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K162951 | TUBETECH IV Administration SetFPA · Traditional | 07/28/2017SE |
| K954428 | Solopicc 24 (60CM) 20GA CatheterFOZ · Traditional | 03/28/1996SE |
| K941628 | 40 Micron Blood Transfusion FilterFPB · Traditional | 02/16/1995SE |
| K942101 | 4-LEAD Irrigation SetHRX · Traditional | 09/30/1994SE |
| K941453 | Check Valve Solution SetFPA · Traditional | 08/16/1994SE |
| K930854 | Solution Set with .2 Micron FilterFPA · Traditional | 01/14/1994SE |
| K932637 | Subcutaneous Infusion SetFPA · Traditional | 01/07/1994SE |
| K931659 | 3 Lead ConnectorFPA · Traditional | 01/07/1994SE |
| K931658 | In-Line Burette SetFPA · Traditional | 12/21/1993SE |
| K932638 | Huber Needle Infusion SetFPA · Traditional | 12/14/1993SE |
Questions and answers
When was Solo Picc/Midline Catheter Kit Models 71924, 71908 cleared by the FDA?
Solo Picc/Midline Catheter Kit Models 71924, 71908 (K961155) received a 510(k) decision of Substantially Equivalent on June 18, 1996, 88 days after the submission was received.
What is the product code of K961155?
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.