510(k) K920088

CAMINO VENTRICULAR NEEDLE by Camino Laboratories, Inc. — Product Code HCD

K920088 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "CAMINO VENTRICULAR NEEDLE". The FDA issued a decision of Substantially Equivalent on May 1, 1992. The device falls under product code HCD (Cannula, Ventricular), a Class I device regulated under 21 CFR 882.4060. Camino Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1992
Date Received
January 8, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Ventricular
Device Class
Class I
Regulation Number
882.4060
Review Panel
NE
Submission Type