Pain Care Multi-Port Catheter, Model 2000L
FDA 510(k) K003611 · Breg, Inc.
510(k) numberK003611
Submission
- Device name
- Pain Care Multi-Port Catheter, Model 2000L
- Applicant
- Breg, Inc.
Vista, CA, US - Received
- November 22, 2000
- Decision date
- December 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K020988 | Pain Care 4200MEB · Special | 04/04/2002SE |
| K013928 | Pain Care 3200MEB · Special | 12/03/2001SE |
| K002073 | Pain Care 3000MEB · Traditional | 09/19/2000SE |
| K002321 | Pain Care 2000LMEB · Special | 08/14/2000SE |
| K983454 | Pain Care 2000MEB · Traditional | 12/16/1998SE |
| K963596 | Polar Care 300ILO · Traditional | 12/04/1996SE |
| K961855 | Polar Care (Model 500/50000)ILO · Traditional | 08/09/1996SE |
Questions and answers
When was Pain Care Multi-Port Catheter, Model 2000L cleared by the FDA?
Pain Care Multi-Port Catheter, Model 2000L (K003611) received a 510(k) decision of Substantially Equivalent on December 13, 2000, 21 days after the submission was received.
What is the product code of K003611?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.