21 C.F.R. § 882.4545 Shunt system implantation instrument.
Title 21 - Food and Drugs
(a) Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin. (b) Classification. Class I (general controls). When made only of surgical grade stainless steel, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §882.9. [44 FR 51730–51778, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000]
Title 21: Food and Drugs
PART 882—NEUROLOGICAL DEVICES
Subpart E—Neurological Surgical Devices
§ 882.4545 Shunt system implantation instrument.
