FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C-FLO SUCTION TUBE
K Number: K882121
·
Decision Jun 20, 1988
Classifications
1
FEI Numbers
172
Registration Numbers
172
Same Product Code
197
Applicant Total
83
Review Days
32
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Basic Information
- Device Name
- C-FLO SUCTION TUBE
- K Number
- K882121
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Concept, Inc.
- Date Received
- May 19, 1988
- Decision Date
- June 20, 1988
- Product Code
- DXQ
- 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 |
|---|---|---|---|
| DXQ | Blood Pressure Cuff | FDA class 2 | Cardiovascular |
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Other Clearances by Concept, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K912640 | CONCEPT ENDOSTEAL FIXATION DEVICE | May 1, 1992 | Substantially Equivalent |
| K912957 | CONCEPT MICROMILL | Oct 4, 1991 | Substantially Equivalent |
| K896648 | CONCEPT UNICOMPARTMENTAL KNEE SYSTEM | Jun 5, 1990 | Substantially Equivalent for Some Indications |
| K894929 | STAPLE FIXATION SYSTEM | Aug 30, 1989 | Substantially Equivalent |
| K892376 | INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.) | Aug 1, 1989 | Substantially Equivalent |
| K891109 | PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE | May 8, 1989 | Substantially Equivalent |
| K881954 | CONCEPT POWER SYSTEM | Nov 9, 1988 | Substantially Equivalent |
| K884255 | CONCEPT CCT-5200, THERMAL THERAPY SYSTEM | Nov 8, 1988 | Substantially Equivalent |
| K880414 | TENDON HARVESTER | Mar 25, 1988 | Substantially Equivalent |
| K874676 | INTERFERENCE SCREW | Mar 7, 1988 | Substantially Equivalent |