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FDA 510(k)

HEARTPORT MAZE SYSTEM: CRYOPROBE SET

K-Number: K970496 · 1997-05-09

ApplicantHeartport, Inc.
Decision Date1997-05-09
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEARTPORT MAZE SYSTEM: CRYOPROBE SET is the device name listed in this FDA 510(k) record. The listed applicant is Heartport, Inc.. It received FDA 510(k) clearance on 1997-05-09 under 510(k) number K970496. 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 HEARTPORT MAZE SYSTEM: CRYOPROBE SET?

HEARTPORT MAZE SYSTEM: CRYOPROBE SET is a medical device that received FDA 510(k) clearance on 1997-05-09. The listed applicant is Heartport, Inc.. The 510(k) number is K970496.

When did HEARTPORT MAZE SYSTEM: CRYOPROBE SET receive FDA 510(k) clearance?

HEARTPORT MAZE SYSTEM: CRYOPROBE SET received FDA 510(k) clearance on 1997-05-09, under 510(k) number K970496.

Who is the listed applicant for HEARTPORT MAZE SYSTEM: CRYOPROBE SET?

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

What is the FDA product code for HEARTPORT MAZE SYSTEM: CRYOPROBE SET?

The FDA product code for HEARTPORT MAZE SYSTEM: CRYOPROBE SET is OCL.

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Other records listing Heartport, 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.

K994243DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIPK981995QUICKDRAW VENOUS CANNULAK990772DIRECTFLOW ARTERIAL CANNULAK981009HEARTPORT ENDOPULMONARY VENT CATHETERK974736HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCERK974175HEARTPORT ENDOAORTIC CLAMP CATHETER

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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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