FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
K Number: K021864
·
Decision Sep 23, 2002
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
9
Review Days
109
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Basic Information
- Device Name
- PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
- K Number
- K021864
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Primeline Medical Products, Inc.
- Date Received
- June 6, 2002
- Decision Date
- September 23, 2002
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Primeline Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023266 | PRIMAGARD SURGICAL GOWNS | Nov 8, 2002 | Substantially Equivalent |
| K023117 | PRIMAGARD SURGICAL GOWNS | Nov 8, 2002 | Substantially Equivalent |
| K022868 | PRIMAGARD SURGICAL EQUIPMENT DRAPES | Nov 8, 2002 | Substantially Equivalent |
| K021076 | PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM | Apr 16, 2002 | Substantially Equivalent |
| K011789 | PROCEDURE MASKS: PM4-301 AND PM4-304 | Jun 22, 2001 | Substantially Equivalent |
| K001951 | PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 | Sep 8, 2000 | Substantially Equivalent |
| K971076 | PRIMED SHOE COVERS, PRIMED HEAD COVERS | Jan 13, 1998 | Substantially Equivalent |
| K971075 | PRIMED PRIME-PLUS COTTON GAUZE SPONGES | Jun 22, 1997 | Substantially Equivalent |