FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VANISHPOINT BLOOD COLLECTION SET
K Number: K122355
·
Decision Aug 23, 2013
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
13
Review Days
385
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Basic Information
- Device Name
- VANISHPOINT BLOOD COLLECTION SET
- K Number
- K122355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Retractable Technologies, Inc.
- Date Received
- August 3, 2012
- Decision Date
- August 23, 2013
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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Other Clearances by Retractable Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K202325 | EasyPoint Blood Collection Plus | Apr 9, 2021 | Substantially Equivalent |
| K133635 | EASYPOINT NEEDLE | Jun 17, 2014 | Substantially Equivalent |
| K112512 | VANISHPOINT BLOOD COLLECTION SET | Oct 20, 2011 | Substantially Equivalent |
| K101708 | PATIENT SAFE LUER CAP | Feb 24, 2011 | Substantially Equivalent |
| K081420 | VANISHPOINT I.V. CATHETER | Nov 7, 2008 | Substantially Equivalent |
| K072654 | PATIENT SAFE SYRINGE | Dec 14, 2007 | Substantially Equivalent |
| K051355 | VANISHPOINT I.V. CATHETER | Sep 23, 2005 | Substantially Equivalent |
| K980069 | VANISHPOINT SYRINGE | Feb 12, 1998 | Substantially Equivalent |
| K973301 | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE | Nov 7, 1997 | Substantially Equivalent |
| K971763 | BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER | Aug 26, 1997 | Substantially Equivalent |