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FDA 510(k)

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C

K-Number: K011988 · 2001-09-20

ApplicantCardiofocus, Inc.
Decision Date2001-09-20
Product CodeOCL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C is the device name listed in this FDA 510(k) record. The listed applicant is Cardiofocus, Inc.. It received FDA 510(k) clearance on 2001-09-20 under 510(k) number K011988. 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 SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C?

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C is a medical device that received FDA 510(k) clearance on 2001-09-20. The listed applicant is Cardiofocus, Inc.. The 510(k) number is K011988.

When did SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C receive FDA 510(k) clearance?

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C received FDA 510(k) clearance on 2001-09-20, under 510(k) number K011988.

Who is the listed applicant for SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C?

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

What is the FDA product code for SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C?

The FDA product code for SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C is OCL.

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Other records listing Cardiofocus, 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.

K152310HeartLight Deflectable SheathK013201CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NRK013901MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)K993834SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C

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.

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Official Source

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