VENTRICULAR ACCESS SYSTEM
FDA 510(k) clearance K823790 · decided 1983-04-28
Clearance details
- K-number
- K823790
- Device name
- VENTRICULAR ACCESS SYSTEM
- Applicant
- American Heyer Schulte
- Decision
- Substantially Equivalent
- Date received
- 1982-12-16
- Decision date
- 1983-04-28
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- LKG
- Device class
- 2
- Regulation number
- 882.5550
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CORDIS CSF RESERVOIR (K950315) | Cordis Corp. | 1995-05-09 |
| PORT-A-CATH PORTAL INTRODUCER FORCEPS (K881690) | Pharmacia Deltec, Inc. | 1988-05-20 |
| PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. (K881493) | Pharmacia Deltec, Inc. | 1988-05-20 |
| P-S MEDICAL VENTRICULAR ACCESS PORT (K874468) | Pudenz-Schulte Medical Research Corp. | 1988-02-11 |
| CSF-VENTRICULOSTOMY RESERVOIR (K874498) | Pudenz-Schulte Medical Research Corp. | 1988-02-11 |
| P-S MEDICAL CSF ACCESS DEV 15MM/25MM (K833822) | Pudenz-Schulte Medical Research Corp. | 1984-05-25 |
| HH SUBCUTANEOUS ACCESS PORT (K833672) | Holter-Hausner Intl. | 1984-03-06 |
Recalls involving this device
No recalls on record reference this clearance.