Modification to Pajunk Stimulong Plus Catheter Sets
FDA 510(k) K043130 · Pajunk GmbH
510(k) numberK043130
Submission
- Device name
- Modification to Pajunk Stimulong Plus Catheter Sets
- Applicant
- Pajunk GmbH
Corvallis, OR, US - Received
- November 12, 2004
- Decision date
- December 21, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAZ – Anesthesia Conduction Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5140
- Specialty
- Anesthesiology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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More from Smiths Medical Asd, Inc.
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| K113207 | Sono Tap, Tuohy SonoBSP · Traditional | 02/29/2012SE |
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| K053283 | Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline SetCAZ · Special | 01/12/2006SE |
| K053282 | Adaptable Monopolar Electrodes with Ceramic TipGEI · Special | 12/13/2005SE |
| K042979 | Modification to: Plexalong SetsBSP · Special | 12/21/2004SE |
| K040965 | Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesBSP · Traditional | 09/07/2004SE |
| K033018 | Stimulong Plus Catheter Set Model, VariousCAZ · Traditional | 05/05/2004SE |
| K033249 | Pajunk Modular Handle InstrumentsGCJ · Traditional | 03/05/2004SE |
| K023218 | Modification to Plexolong SetsBSP · Special | 03/24/2003SE |
Questions and answers
When was Modification to Pajunk Stimulong Plus Catheter Sets cleared by the FDA?
Modification to Pajunk Stimulong Plus Catheter Sets (K043130) received a 510(k) decision of Substantially Equivalent on December 21, 2004, 39 days after the submission was received.
What is the product code of K043130?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.