# Balt USA, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 20 (2018–2026): 19 510(k) clearances and 1 original PMA approval
- Product codes: QJP (6), HCG (5), NRY (2), KRA (2), KRD (1), MJN (1), DQY (1), MOF (1), SGU (1)
- 510(k) review time since 2016: median 153 days, against 117 for FDA's reviews in the same codes and years (8 of 17 faster)
- Predicates its devices cite: 20 (8 its own); citations of its devices by later devices: 10 (8 its own)
- Recalls linked to its devices: 6 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- MicroVention, Inc.: 3 (https://510kreport.com/company/microvention)
- Imperative Care, Inc.: 2 (https://510kreport.com/company/imperative-care)
- Penumbra, Inc.: 2 (https://510kreport.com/company/penumbra)
- Blockade Medical, LLC (D.B.A. Balt Usa): 1 (https://510kreport.com/company/blockade-medical-dba-balt-usa)
- Bait USA, LLC: 1 (https://510kreport.com/company/bait-usa)
- Advanced Interventional Technologies, LLC: 1 (https://510kreport.com/company/advanced-interventional-technologies)
- Route 92 Medical, Inc.: 1 (https://510kreport.com/company/route-92-medical)
- Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular: 1 (https://510kreport.com/company/micro-therapeutics-lnc-d-b-a-ev3-neurovascular)

## Firms that cite its devices most
- Bait USA, LLC: 1 (https://510kreport.com/company/bait-usa)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)

## Its most-cited devices
- K200030: Optima Coil System (2020), cited by 2
- K234074: Next Generation Access Catheter (2024), cited by 1
- K230609: NG Delivery Catheter (2023), cited by 1
- K202366: MAGIC Infusion Catheter (2021), cited by 1
- K252700: Optima Coil System (Optima Packing Coil System) (2025), cited by 1
- K182918: Ballast 088 Long Sheath (2019), cited by 1

## Recent decisions
- K260199: SLIM Microcatheter (Jul 13, 2026)
- K254223: Next Generation 088 Catheter (Apr 16, 2026)
- P250009: SQUID Liquid Embolic Agent (LEA) (Jan 30, 2026)
- K254221: Optima Coil System (OptiOne Coil System) (Jan 27, 2026)
- K252569: Carrier XL Delivery Catheter (Oct 22, 2025)
- K252700: Optima Coil System (Optima Packing Coil System) (Sep 26, 2025)
- K243948: Raptor Aspiration Catheter; Balt Aspiration Tubing Set (Jun 3, 2025)
- K251383: Prestige Coil System (Prestige Packing Line Extension) (May 30, 2025)

Source page: https://510kreport.com/company/balt-usa