FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE WAND MICROACCESS SAFETY INTRODUCER
K Number: K090372
·
Decision Mar 30, 2009
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
682
Applicant Total
8
Review Days
45
Basic Information
- Device Name
- THE WAND MICROACCESS SAFETY INTRODUCER
- K Number
- K090372
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ACCESS SCIENTIFIC, INC.
- Date Received
- February 13, 2009
- Decision Date
- March 30, 2009
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by ACCESS SCIENTIFIC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K121748 | THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL | Jul 27, 2012 | Substantially Equivalent |
| K111417 | THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | Jul 15, 2011 | Substantially Equivalent |
| K111138 | THE PICC WAND (R) PEELABLE SAFETY INTRODUCER | Jun 22, 2011 | Substantially Equivalent |
| K101422 | THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER | Mar 22, 2011 | Substantially Equivalent |
| K101150 | PICC WAND PEELABLE SAFETY INTRODUCER | Aug 13, 2010 | Substantially Equivalent |
| K093022 | THE PICC WAND PEELABLE SAFETY INTRODUCER | Jan 20, 2010 | Substantially Equivalent |
| K081697 | THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 | Dec 4, 2008 | Substantially Equivalent |