FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRO-VENT, LINE DRAW, PULSATOR
K Number: K952516
·
Decision Jul 14, 1995
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
22
Review Days
44
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Basic Information
- Device Name
- PRO-VENT, LINE DRAW, PULSATOR
- K Number
- K952516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smiths Industries Medical Systems, Inc.
- Date Received
- May 31, 1995
- Decision Date
- July 14, 1995
- 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 Smiths Industries Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972385 | FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED | Jan 20, 1998 | Substantially Equivalent |
| K965017 | REGIONAL ANESTHESIA TRAYS | Mar 14, 1997 | Unknown |
| K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE | Jan 17, 1997 | Substantially Equivalent |
| K962931 | SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT | Oct 21, 1996 | Substantially Equivalent |
| K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) | Oct 18, 1996 | Substantially Equivalent |
| K960429 | PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA | May 2, 1996 | Unknown |
| K953485 | SIMS CPAP SYSTEM | Oct 26, 1995 | Substantially Equivalent |
| K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE | Oct 24, 1995 | Substantially Equivalent |
| K932946 | WALLACE IV CANNULA | Sep 1, 1995 | Substantially Equivalent |
| K932947 | WALLACE Y-CAN | Sep 1, 1995 | Substantially Equivalent |