On-Q Catheter, On-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter
FDA 510(k) K051401 · I-Flow Corp.
510(k) numberK051401
Submission
- Device name
- On-Q Catheter, On-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter
- Applicant
- I-Flow Corp.
Lake Forest, CA, US - Received
- May 31, 2005
- Decision date
- November 30, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
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| K241410 | EDEN ControlCathBSO · Traditional | Jmt Co., Ltd. | 02/13/2025SE |
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| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | Teleflex Medical | 08/30/2023SE |
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| K191470 | C-CAT Anaesthesia Catheter kitBSO · Traditional | Cimpax Aps | 10/25/2019SE |
| K181782 | Medline Reinforced Epidural CatheterBSO · Traditional | Medline Industries, Inc. | 03/04/2019SE |
| K173541 | EpinautBSO · Traditional | Imedicom Co., Ltd. | 08/24/2018SE |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional | PAJUNK GmbH Medizintechnologie | 05/03/2018SE |
| K171584 | B. Braun Tear-Away Introducer NeedleBSO · Traditional | B.Braun Medical, Inc. | 12/22/2017SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131249 | On-Q Painbuster, On-Q C-Bloc, Homepump Eclipse, Homepump C-SeriesMEB · Traditional | 02/03/2014SE |
| K063530 | On-Q, Painbuster, C-Bloc, Select-A-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step…MEB · Special | 01/26/2007SE |
| K063234 | On-Q IntroducersBSO · Abbreviated | 11/21/2006SE |
| K052117 | I-Flow Elastomeric Pump (On-Q, Painbuster, C-Block, Homepump, Easypump)MEB · Special | 09/09/2005SE |
| K043456 | Modification to Soaker CatheterBSO · Special | 01/11/2005SE |
| K040337 | I-Flow Elastomeric Pump (On-Q, Painbuster, C-Bloc, Homepump)MEB · Traditional | 05/24/2004SE |
| K023883 | Homepump, Eclipse, C-Series, Painbuster, C-Bloc, On-Q, Easypump, KvoMEB · Special | 12/20/2002SE |
| K023827 | Paragon Infusion System with BolusFRN · Special | 12/13/2002SE |
| K023318 | I-Flow Elastomeric Pump with BolusMEB · Special | 10/18/2002SE |
| K022869 | Soaker CatheterFRN · Special | 09/20/2002SE |
Questions and answers
When was On-Q Catheter, On-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter cleared by the FDA?
On-Q Catheter, On-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter (K051401) received a 510(k) decision of Substantially Equivalent on November 30, 2005, 183 days after the submission was received.
What is the product code of K051401?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.