Vitacuff(R) Percutaneous Infect. Control Kit
FDA 510(k) K882100 · Vitaphore Corp.
510(k) numberK882100
Submission
- Device name
- Vitacuff(R) Percutaneous Infect. Control Kit
- Applicant
- Vitaphore Corp.
San Carlos, CA, US - Received
- May 19, 1988
- Decision date
- July 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K914579 | Silver Foam Wound DressingFRO · Traditional | 02/21/1992SE |
| K913148 | Collagen Shield for Acute CareMOE · Traditional | 10/15/1991SE |
| K895920 | Vitapatch Pin Protection Device for PercutaneousKGX · Traditional | 06/06/1991SE |
| K902558 | Collagen Shield for Acute CareMOE · Traditional | 08/17/1990SE |
| K891993 | Collagen NeurospongeHBA · Traditional | 03/23/1990SE |
| K896455 | Vitachoice Wound DressingKGX · Traditional | 02/15/1990SE |
| K896046 | Vitapatch Cath. Securement Device W/ChlorhexidineKMK · Traditional | 01/11/1990SE |
| K895993 | Vitapatch Antimicrobial Catheter Securement DeviceKMK · Traditional | 01/11/1990SE |
| K890435 | Vitaaccess Catheter Introducer KitFOZ · Traditional | 03/29/1989SESD |
| K872998 | Vitaaccess (TM) Catheter Introducer SystemFOZ · Traditional | 03/24/1988SE |
Questions and answers
When was Vitacuff(R) Percutaneous Infect. Control Kit cleared by the FDA?
Vitacuff(R) Percutaneous Infect. Control Kit (K882100) received a 510(k) decision of Substantially Equivalent on July 13, 1988, 55 days after the submission was received.
What is the product code of K882100?
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.