DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
Device Facts
| Record ID | K914985 |
|---|---|
| Device Name | DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION |
| Applicant | E-Z-Em, Inc. |
| Product Code | DRC · Cardiovascular |
| Decision Date | Dec 20, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1390 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.
Special Controls
*Classification.* Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
