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FDA 510(k)

CUSTOM CV PACK

K-Number: K936255 · 1994-03-31

ApplicantAssociated Medical
Decision Date1994-03-31
Product CodeKDD
Advisory CommitteeSU
DecisionSubstantially Equivalent for Some Indications

Device Summary

CUSTOM CV PACK is the device name listed in this FDA 510(k) record. The listed applicant is Associated Medical. It received FDA 510(k) clearance on 1994-03-31 under 510(k) number K936255. The device is classified under product code KDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CUSTOM CV PACK?

CUSTOM CV PACK is a medical device that received FDA 510(k) clearance on 1994-03-31. The listed applicant is Associated Medical. The 510(k) number is K936255.

When did CUSTOM CV PACK receive FDA 510(k) clearance?

CUSTOM CV PACK received FDA 510(k) clearance on 1994-03-31, under 510(k) number K936255.

Who is the listed applicant for CUSTOM CV PACK?

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

What is the FDA product code for CUSTOM CV PACK?

The FDA product code for CUSTOM CV PACK is KDD.

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 Associated Medical 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.

K935621CUSTOM ENT PACKSK935622CUSTOM PLASTIC PACKS

Related Devices (Code: KDD)

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.

K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidienK011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.K932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products Co.K923176SURGICAL INSTRUMENT KIT, DISPOSABLEUlti-Med Intl., Inc.

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.

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