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FDA 510(k)

CRYOCARE CARDIAC SURGICAL SYSTEM

K-Number: K011040 · 2001-06-15

ApplicantEndocare, Inc.
Decision Date2001-06-15
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYOCARE CARDIAC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endocare, Inc.. It received FDA 510(k) clearance on 2001-06-15 under 510(k) number K011040. The device is classified under product code OCL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOCARE CARDIAC SURGICAL SYSTEM?

CRYOCARE CARDIAC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 2001-06-15. The listed applicant is Endocare, Inc.. The 510(k) number is K011040.

When did CRYOCARE CARDIAC SURGICAL SYSTEM receive FDA 510(k) clearance?

CRYOCARE CARDIAC SURGICAL SYSTEM received FDA 510(k) clearance on 2001-06-15, under 510(k) number K011040.

Who is the listed applicant for CRYOCARE CARDIAC SURGICAL SYSTEM?

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

What is the FDA product code for CRYOCARE CARDIAC SURGICAL SYSTEM?

The FDA product code for CRYOCARE CARDIAC SURGICAL SYSTEM is OCL.

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Other records listing Endocare, Inc. 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.

K101333CRYOCARE CS SURGICAL SYSTEMK062175CRYOCARE CN2 SYSTEMK060279CRYOCARE CS SURGICAL SYSTEMK050347MODIFICATION TO CRYOCARE CS SURGICAL SYSTEMK032333CRYOCARE CS SURGICAL SYSTEMK023757CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20

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Related Devices (Code: OCL)

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.

K252056Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)AtriCure, Inc.K234151Isolator Synergy EnCapture Ablation System (EMH)AtriCure, Inc.K221358Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)AtriCure, Inc.K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation DeviceMedtronic, Inc.K210477AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDEAtriCure, Inc.K211311AtriCure Isolator® Synergy™ Surgical Ablation SystemAtriCure, 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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