FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
K Number: K043249
·
Decision May 25, 2005
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
9
Review Days
183
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Basic Information
- Device Name
- ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE
- K Number
- K043249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atrion Medical Products, Inc.
- Date Received
- November 23, 2004
- Decision Date
- May 25, 2005
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Atrion Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060643 | QL LOCKING SYRINGE | Jul 12, 2006 | Substantially Equivalent |
| K041158 | ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM | Jun 16, 2004 | Substantially Equivalent |
| K032840 | ATRION MEDICAL QL INFLATION DEVICE | Mar 3, 2004 | Substantially Equivalent |
| K020333 | ATRION MEDICAL QL FLUID DISPENSING SYRINGE | Apr 25, 2002 | Substantially Equivalent |
| K973633 | ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET | Jan 16, 1998 | Substantially Equivalent |
| K973872 | ATRION MEDICAL COATED LACRIMAL INTUBATION SET | Jan 8, 1998 | Substantially Equivalent |
| K972964 | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | Oct 10, 1997 | Substantially Equivalent |
| K971100 | ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR | May 23, 1997 | Substantially Equivalent |