CAVROPUMP

FDA 510(k) clearance K871129 · decided 1987-08-28

Clearance details

K-number: K871129
Device name: CAVROPUMP
Applicant: Life-Tech Intl., Inc.
Decision: Substantially Equivalent
Date received: 1987-03-20
Decision date: 1987-08-28
Days to decision: 161 days
Clearance type: Traditional
Product code: DXT
Device class: 2
Regulation number: 870.1650
Medical specialty: Cardiovascular
Advisory committee: Cardiovascular
Location: Houston, TX, US
Third-party review: No
Expedited review: No

+ Add to Predicate Builder ◉ Watch Life-Tech Intl.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr (K252652)	Fortis Biosolutions Company Limited	2026-05-14
ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable (K252653)	Acist Medical Systems, Inc.	2026-05-13
VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) (K252638)	Acist Medical Systems, Inc.	2026-05-13
High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube (K253048)	Shenzhen Maiwei Biotech Co., Ltd.	2026-04-16
Extension tube (K251788)	Zhuhai DR Medical Instruments Co., Ltd.	2026-03-05
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) (K252891)	Bayer Medical Care, Inc.	2026-02-13
High Pressure Tubing (K244038)	Shandong Int Medical Instruments Co., Ltd.	2025-09-05
Angiography Injector (K242143)	Shandong Int Medical Instruments Co., Ltd.	2024-12-23
Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (K242212)	Nemoto Kyorindo Co., Ltd.	2024-08-27
Single-use Sterile High-pressure Angiographic Syringes and Accessories (K241109)	Shenzhen Boon Medical Supply Co., Ltd.	2024-08-22
Disposable High-pressure Extension Lines (K230668)	Precision Medical Plastics , Ltd.	2024-06-14
High Pressure Tubing (K232388)	Ningbo Dizegens Medical Science Co.,Ltd	2023-11-21

Recalls involving this device

No recalls on record reference this clearance.