CAZClass II
Anesthesia Conduction Kit
21 CFR 868.5140 / Anesthesiology
CAZ is the FDA product code for Anesthesia Conduction Kit, a class II device type, regulated under 21 CFR 868.5140. FDA's definition for this code reads: "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...". As of , FDA records hold 155 510(k) clearances under this code, the most recent dated , and 220 recalls.
Classification record
- Product code
- CAZ
- Device name
- Anesthesia Conduction Kit
- FDA definition
- 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.
- Regulation
- 21 CFR 868.5140
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 156
- Ingested recalls
- 220
Clearances, product code CAZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 4 |
| 1977 | 4 |
| 1978 | 2 |
| 1979 | 2 |
| 1980 | 3 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 3 |
| 1985 | 4 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 6 |
| 1989 | 14 |
| 1990 | 8 |
| 1991 | 3 |
| 1993 | 8 |
| 1994 | 7 |
| 1995 | 10 |
| 1996 | 9 |
| 1997 | 4 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 4 |
| 2001 | 1 |
| 2002 | 3 |
| 2003 | 3 |
| 2004 | 6 |
| 2005 | 2 |
| 2006 | 6 |
| 2007 | 4 |
| 2008 | 4 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 9 |
| 2015 | 1 |
| 2016 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code CAZ| Applicant | Clearances |
|---|---|
| Pajunk GmbH Medizintechnologie | 13 |
| Arrow Intl., Inc. | 11 |
| Kendall Healthcare Products Co. Div.Of Tyco Health | 9 |
| B.Braun Medical, Inc. | 7 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 7 |
| Life-Tech, Inc. | 5 |
| Medsurg Industries, Inc. | 5 |
| Abbott Medical | 5 |
| Spinal Specialties, Inc. | 5 |
| Arrow International LLC (subsidiary of Teleflex Incorporated) | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Almo-Erzeugnisse Erwin Busch GmbH
- Argon Medical Devices, Inc
- Arrow Internacional de Chihuahua S.A. de C.V.
- Arrow International C.R. A.S.
- Arrow International LLC (subsidiary of Teleflex Incorporated)
- Atrion Medical Products, Inc.
- AVENT S. de R.L. de C.V.
- Avid Medical, Inc. a Medical Action Ind. Company 305
- B Braun Medical Inc
- B. Braun Aesculap Japan Co., Ltd.
- B. Braun Medical Industries Sdn. Bhd.
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