FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
K Number: K121403
·
Decision Jun 20, 2012
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
10
Review Days
41
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Basic Information
- Device Name
- CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
- K Number
- K121403
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teleflex, Inc.
- Date Received
- May 10, 2012
- Decision Date
- June 20, 2012
- Product Code
- CAZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAZ | Anesthesia Conduction Kit | FDA class 2 | Anesthesiology |
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| K123974 | PERCUTANEOUS INTRODUCER KIT | Feb 21, 2013 | Substantially Equivalent |
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| K861951 | MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER | Jun 19, 1986 | Substantially Equivalent |
| K860307 | PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET | May 20, 1986 | Substantially Equivalent |