Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEART PACK II

K-Number: K914935 · 1992-01-31

ApplicantWestmark Hospital Supplies
Decision Date1992-01-31
Product CodeLRO
Advisory CommitteeSU
DecisionUnknown

Device Summary

HEART PACK II is the device name listed in this FDA 510(k) record. The listed applicant is Westmark Hospital Supplies. It received FDA 510(k) clearance on 1992-01-31 under 510(k) number K914935. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the HEART PACK II?

HEART PACK II is a medical device that received FDA 510(k) clearance on 1992-01-31. The listed applicant is Westmark Hospital Supplies. The 510(k) number is K914935.

When did HEART PACK II receive FDA 510(k) clearance?

HEART PACK II received FDA 510(k) clearance on 1992-01-31, under 510(k) number K914935.

Who is the listed applicant for HEART PACK II?

The FDA 510(k) record lists Westmark Hospital Supplies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEART PACK II?

The FDA product code for HEART PACK II is LRO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Westmark Hospital Supplies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K914934HAND PACKK914928BASIC SET UP TRAYK914933HEART PACK IIIK914927DRESSING CHANGE KITK914929LACERATION TRAYK914932SUTURE REMOVAL KIT

View all 7 devices →

Related Devices (Code: LRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑