# K831931: Atrium Thoracic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corp.
- Decided: Oct 4, 1983 after 111 days
- Product code: GBZ (Catheter, Cholangiography)
- Device class: 1
- Regulation: 21 CFR 878.4200
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 29, 2023 · Class II · Z-0484-2024: A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
- Oct 12, 2018 · Class II · Z-0560-2019: This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not det
- Jan 20, 2017 · Class II · Z-1222-2017: Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
- Jan 20, 2017 · Class II · Z-1221-2017: Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets on the 8 Fr and 10 Fr thoracic catheters is two (2)
- Oct 26, 2016 · Class II · Z-0577-2017: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
- Oct 26, 2016 · Class II · Z-0576-2017: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
- Oct 26, 2016 · Class II · Z-0578-2017: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
- Oct 26, 2016 · Class II · Z-0579-2017: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
- Oct 26, 2016 · Class II · Z-0580-2017: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
- Oct 26, 2016 · Class II · Z-0582-2017: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
- Oct 26, 2016 · Class II · Z-0583-2017: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
- Oct 26, 2016 · Class II · Z-0581-2017: Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
- Jun 19, 2015 · Class II · Z-2346-2015: Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter

Source page: https://510kreport.com/device/K831931
Methodology: https://510kreport.com/methodology