FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
K Number: K953681
·
Decision Jun 4, 1996
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
28
Review Days
302
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Basic Information
- Device Name
- HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
- K Number
- K953681
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Haemonetics Corp.
- Date Received
- August 7, 1995
- Decision Date
- June 4, 1996
- Product Code
- LKN
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKN), ordered by most recent decision date.
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AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
FDA 510(k)
FDA Unclassified
·Unknown
Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Haemonetics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122262 | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM | Oct 25, 2012 | Substantially Equivalent |
| K120586 | CELL SAVER ELITE | May 22, 2012 | Substantially Equivalent |
| K101907 | HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM | Dec 3, 2010 | Substantially Equivalent |
| K062801 | SMARTSUCTION SOLO DEVICE | Oct 4, 2006 | Substantially Equivalent |
| K061103 | HAEMONETICS 40U RBC FILTER BAG | May 17, 2006 | Substantially Equivalent |
| K053000 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) | Nov 21, 2005 | Substantially Equivalent |
| K052626 | SMARTSUCTION HARMONY DEVICE | Oct 5, 2005 | Substantially Equivalent |
| K043127 | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM | Jan 4, 2005 | Substantially Equivalent |
| K014083 | HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM | Jan 8, 2002 | Substantially Equivalent |
| K993581 | HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER | Nov 18, 1999 | Substantially Equivalent |