Pharmacia Deltec Peripherally Inserted Venous Cath
FDA 510(k) K932198 · Pharmacia Deltec, Inc.
510(k) numberK932198
Submission
- Device name
- Pharmacia Deltec Peripherally Inserted Venous Cath
- Applicant
- Pharmacia Deltec, Inc.
St. Paul, MN, US - Received
- May 6, 1993
- Decision date
- May 2, 1994
- Decision
- Unknown (SESK)
- 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 |
|---|---|---|
| K943310 | Model 6100 Ambulatory Infusion SystemMEA · Traditional | 02/21/1995ST |
| K942046 | Pharmacia Deltec Extension Set with Anti-Siphon ValveFPA · Traditional | 10/04/1994SE |
| K942161 | LockboxFRN · Traditional | 08/02/1994ST |
| K942024 | Port-A-Cath Low Profile Implantable Venous Access SystemLJT · Traditional | 07/26/1994SE |
| K941445 | Extension Set with Anti-Siphon ValveFPA · Traditional | 06/29/1994SE |
| K931073 | Cath-FinderFOZ · Traditional | 05/05/1994SE |
| K932464 | Peripherallyinsrted Venous Cath. Alternate Cath.LJS · Traditional | 05/02/1994SESK |
| K932433 | Pheripherally Inserted Venous Catheter-Y SiteLJS · Traditional | 05/02/1994SESK |
| K932430 | Dual Lumen Peripherally Inserted Venous CatheterLJS · Traditional | 05/02/1994SESK |
| K932211 | Procedural Tray for Peripherally Inserted VenousLJS · Traditional | 05/02/1994SE |
Questions and answers
When was Pharmacia Deltec Peripherally Inserted Venous Cath cleared by the FDA?
Pharmacia Deltec Peripherally Inserted Venous Cath (K932198) received a 510(k) decision of Unknown on May 2, 1994, 361 days after the submission was received.
What is the product code of K932198?
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.