Loper Celiac Plexus Block Catheter Kit
FDA 510(k) K895955 · Opticon Medical, Inc.
510(k) numberK895955
Submission
- Device name
- Loper Celiac Plexus Block Catheter Kit
- Applicant
- Opticon Medical, Inc.
Gurnee, IL, US - Received
- October 11, 1989
- Decision date
- February 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 10/04/2016SE |
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| K122690 | Ultraquik Peripheral Nerve Block NeedleCAZ · Traditional | Arrow International, Inc. | 12/21/2012SE |
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More from Smiths Medical Asd, Inc.
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|---|---|---|
| K041983 | Option-Vm Urinary Catheter/Adpater, Models MV39016, MVA39016EZL · Traditional | 11/17/2004SE |
| K033830 | Option-Vf Urinary Catheter with Adaptor, Model FVA14218; Option-V Continuous Drainage…EZL · Special | 01/09/2004SE |
| K023090 | Option-Vf Urinary Catheter, FV14218EZL · Traditional | 03/19/2003SE |
| K970716 | Opticon Direct Male Urinary Catheter for Continuous DrainageEZL · Traditional | 05/16/1997SE |
| K930194 | Hemostasis Valve and Tubing SetDYB · Traditional | 09/22/1993SE |
| K904999 | Weingarten TM Capnographic Intubation StyletteBSR · Traditional | 01/26/1993SE |
| K895476 | Option Epidural CathetersCAZ · Traditional | 01/19/1990SE |
Questions and answers
When was Loper Celiac Plexus Block Catheter Kit cleared by the FDA?
Loper Celiac Plexus Block Catheter Kit (K895955) received a 510(k) decision of Substantially Equivalent on February 22, 1990, 134 days after the submission was received.
What is the product code of K895955?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.