FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
K Number: K994059
·
Decision Oct 13, 2000
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
154
Applicant Total
30
Review Days
319
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Basic Information
- Device Name
- CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
- K Number
- K994059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5140
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hdc Corp.
- Date Received
- November 29, 1999
- Decision Date
- October 13, 2000
- 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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|---|---|---|---|
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| K032404 | SELDINGER SAFETY NEEDLE INTRODUCER | Sep 10, 2003 | Substantially Equivalent |
| K022752 | PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 | Sep 9, 2003 | Substantially Equivalent |
| K022099 | SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S | Sep 20, 2002 | Substantially Equivalent |
| K010425 | EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) | Mar 15, 2001 | Substantially Equivalent |
| K002770 | IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 | Sep 26, 2000 | Substantially Equivalent |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | Mar 15, 1999 | Substantially Equivalent |
| K983916 | V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) | Nov 23, 1998 | Substantially Equivalent |