FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIGHT ATRIAL CATHETER
K Number: K840742
·
Decision Jul 13, 1984
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
29
Review Days
161
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Basic Information
- Device Name
- RIGHT ATRIAL CATHETER
- K Number
- K840742
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- The Healthcare Group Laboratories, Inc.
- Date Received
- February 3, 1984
- Decision Date
- July 13, 1984
- Product Code
- LJS
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by The Healthcare Group Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K850035 | EMPTY SOLUTION TRANSFER CONTAINER | Jun 7, 1985 | Substantially Equivalent |
| K842170 | EMPTY SOLUTION TRANSFER CONTAINER | Oct 19, 1984 | Substantially Equivalent |
| K842091 | DISPOS. ACU-CUT SOFT TISSUE BIOPSY | Jul 23, 1984 | Substantially Equivalent |
| K830299 | SOLUTION TRANSFER CONTAINER | Feb 19, 1983 | Substantially Equivalent |
| K822307 | ADHESIVE SPRAY #4050-4060 | Sep 24, 1982 | Substantially Equivalent |
| K822059 | SHOW'RBAG | Jul 22, 1982 | Substantially Equivalent |
| K821480 | RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT | Jun 17, 1982 | Substantially Equivalent |
| K821230 | SOFTIC 49 | May 28, 1982 | Substantially Equivalent |
| K821162 | ADHESIVE REMOVER | May 14, 1982 | Substantially Equivalent |
| K821172 | EXTERNAL FEMALE URINARY INCONTINENCE | May 10, 1982 | Substantially Equivalent |