Kendall Argyle Neonatal/Pediatric Picc, Model 43311
FDA 510(k) K061936 · The Kendall Company
510(k) numberK061936
Submission
- Device name
- Kendall Argyle Neonatal/Pediatric Picc, Model 43311
- Applicant
- The Kendall Company
Mansfield, MA, US - Received
- July 10, 2006
- Decision date
- August 9, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K092797 | Acute and Chronic Catheter Repair KitNFK · Traditional | 11/19/2009SESK |
| K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…MSD · Special | 11/03/2006SESK |
| K060972 | Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)MSD · Traditional | 08/04/2006SE |
| K053410 | Gientriport with Universal Single Lumen AdaptorFEG · Traditional | 01/06/2006SE |
| K051584 | 14.5 FR Chronic Hemodialysis Catheter with Insertion Stylets AccessoryMSD · Special | 10/06/2005SE |
| K043272 | Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical TipMSD · Special | 12/22/2004SE |
| K042461 | Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304LJS · Abbreviated | 12/10/2004SE |
| K042572 | Kendall CO2NFIRM Now CO2 DetectorKNT · Traditional | 11/05/2004SE |
| K041914 | Pallindrome 14.5FR Chronic Hemodialysis CatheterMSD · Traditional | 09/27/2004SE |
| K041006 | Tandem-Cath Hemodialysis Catheter, Model 10 FRMSD · Special | 05/19/2004SE |
Questions and answers
When was Kendall Argyle Neonatal/Pediatric Picc, Model 43311 cleared by the FDA?
Kendall Argyle Neonatal/Pediatric Picc, Model 43311 (K061936) received a 510(k) decision of Substantially Equivalent on August 9, 2006, 30 days after the submission was received.
What is the product code of K061936?
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.