FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SWABBABLE CAP, MODEL 60205
K Number: K070163
·
Decision Aug 3, 2007
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
198
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Basic Information
- Device Name
- SWABBABLE CAP, MODEL 60205
- K Number
- K070163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxa Corp.
- Date Received
- January 17, 2007
- Decision Date
- August 3, 2007
- Product Code
- ODI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| ODI | Administration Set Docking Station | FDA class 2 | General Hospital |
Other Clearances by Baxa Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K090917 | SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | Feb 19, 2010 | Substantially Equivalent |
| K062909 | REPEATER PUMP II TUBE SETS | Mar 9, 2007 | Substantially Equivalent |
| K022523 | RAPID-FILL TUBESET, MODEL 90005 | Aug 12, 2002 | Substantially Equivalent |
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 | Mar 28, 2001 | Substantially Equivalent |
| K983321 | MICROFUSE DUAL RATE INFUSER | Oct 6, 1998 | Substantially Equivalent |
| K951871 | PISTON SYRINGE | Jun 21, 1995 | Substantially Equivalent |
| K933506 | SYRINGE INFUSER | Feb 25, 1994 | Substantially Equivalent |