# K011727: Transseptal Needle/Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Thomas Medical Products, Inc.
- Decided: May 2, 2002 after 332 days
- Product code: DRC (Trocar)
- Device class: 2
- Regulation: 21 CFR 870.1390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cook, Transseptal Needle: named in the summary without a submission number
- (no number) Daig, Transseptal Needle: named in the summary without a submission number
- (no number) C.R. Bard, USCI® Brockenbrough® Needles and Accessories: named in the summary without a submission number

## Most influential descendants
- K073326: NRG Transseptal Needle (2008), 16 descendants of its own
- K072278: BRK Transseptal Needle (2007), 8 descendants of its own
- K150709: ProTrack RF Anchor Wire (2015), 7 descendants of its own
- K122587: BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208 (2013), 6 descendants of its own
- K232852: Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable (2023), 3 descendants of its own

## Recalls of this device
- Mar 15, 2016 · Class II · Z-1375-2016: Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the pac

## Indications for use
Used to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

Source page: https://510kreport.com/device/K011727
Methodology: https://510kreport.com/methodology