510(k) K011727

TRANSSEPTAL NEEDLE/TROCAR by Thomas Medical Products, Inc. — Product Code DRC

K011727 is an FDA 510(k) premarket notification submitted by Thomas Medical Products, Inc. for the device "TRANSSEPTAL NEEDLE/TROCAR". The FDA issued a decision of Substantially Equivalent on May 2, 2002. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Thomas Medical Products, Inc. has at least 10 other 510(k) clearances on record.