FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT
K Number: K821480
·
Decision Jun 17, 1982
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
29
Review Days
30
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Basic Information
- Device Name
- RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT
- K Number
- K821480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- The Healthcare Group Laboratories, Inc.
- Date Received
- May 18, 1982
- Decision Date
- June 17, 1982
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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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 |
| K840742 | RIGHT ATRIAL CATHETER | Jul 13, 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 |
| 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 |