FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
K Number: K875353
·
Decision Mar 22, 1988
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
56
Review Days
82
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Basic Information
- Device Name
- PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
- K Number
- K875353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Dlp, Inc.
- Date Received
- December 31, 1987
- Decision Date
- March 22, 1988
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Dlp, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973485 | CLEARVIEW BLOWER/MISTER | Dec 8, 1997 | Substantially Equivalent |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | Jan 30, 1997 | Substantially Equivalent |
| K953945 | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET | Mar 26, 1996 | Substantially Equivalent |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | Apr 25, 1995 | Substantially Equivalent |
| K934215 | CONTAIN-OR | Feb 9, 1994 | Substantially Equivalent |
| K915268 | CATHETER TWO STAGE VENOUS RETURN | Jul 27, 1992 | Substantially Equivalent |
| K913077 | LANCASTER COOLING JACKET, CAT. CODE #13500/13501 | Jan 9, 1992 | Substantially Equivalent |
| K914608 | BREAST LES LOCAL WIRE ST. 48219/49220/48119/48120 | Jan 9, 1992 | Substantially Equivalent |
| K913098 | APIRATION BIOPSY SYRINGE GUN, CAT. CODE #54501 | Nov 5, 1991 | Substantially Equivalent |
| K912229 | IMA ELECTROCAUTERY ELECTRODE CAT. #60002/60003 | Sep 25, 1991 | Substantially Equivalent |